Methods for treatment of hypertension with an angiotensin ii receptor blocker pharmaceutical composition

ABSTRACT

A method is provided for lowering blood pressure in a subject in need thereof by administering an angiotensin II receptor blocker pharmaceutical composition to a subject qualified for over-the-counter access to the angiotensin II receptor blocker pharmaceutical composition. In some embodiments, the angiotensin II receptor blocker pharmaceutical composition includes azilsartan medoxomil, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, or valsartan. In some embodiments, the angiotensin II receptor blocker pharmaceutical composition comprises an active ingredient that is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate or a pharmaceutically acceptable salt thereof.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 62/685,209, filed Jun. 14, 2018, and claims priority to U.S.Provisional Patent Application Ser. No. 62/848,902, filed May 16, 2019,both of which are hereby incorporated by reference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to methods for lowering bloodpressure, e.g., thereby treating and/or preventing heart disease, byadministering an over-the-counter angiotensin II receptor blockerpharmaceutical composition to a subject in need thereof, who has beenqualified for over-the-counter access to the composition.

BACKGROUND

Hypertension, e.g., high blood pressure, is the leading cause of deathworldwide and the second-leading cause of preventable death in theUnited States. Roberts, N., et al., Emitro Health, “Feeling the Pressureof New Guidelines for the Treatment of Hypertension,” (2017). As of2014, according to the CDC, 1 in 3 adults in the U.S. was inflicted withhigh blood pressure and about 46% of those individuals did not havetheir blood pressure under control. Merai R., et al., MMWR Morb MortalWkly Rep, 65:1261-1264 (2016). Of the approximately 35 million U.S.citizens that do not have their blood pressure under control, about 20%are aware that they have high blood pressure, yet are not being treated.Id. The CDC estimates that $49 billion is spent annually in direct andindirect medical expenses relating to uncontrolled hypertension. Id.

Fortunately, hypertension can be managed, for example, using angiotensinII receptor blockers, which are well established prescriptionpharmaceuticals used to lower blood pressure, thereby preventing heartdisease. For instance, the efficacy of azilsartan medoxomil, which wasfirst approved in the U.S. for the treatment of hypertension in 2011, tolower blood pressure has been demonstrated in at least 5 double-blind,placebo-controlled, randomized studies. However, access to angiotensinII receptor blockers is restricted by the requirement for aprescription. Unfortunately, long-term trends demonstrate many peopleavoid prescription medications, including angiotensin II receptorblockers.

One approach to making angiotensin II receptor blockers more accessibleis to make them available without a prescription, e.g., over the counter(“OTC”). There are a variety of health benefits derived from switching adrug from prescription to OTC including, but not limited to, generatingwider availably to therapies, providing a greater number of therapeuticapproaches, providing direct and rapid access to treatments, providingpatients with an active role in their own health care, and allowingpatients to become self-reliant in preventing and relieving minorsymptoms or conditions (World Health Organization, 2000, “Guidelines forthe Regulatory Assessment of Medicinal Products for use inSelf-Medication,” Print). Given the large number of individuals withuncontrolled high blood pressure, providing access to OTC angiotensin IIreceptor blockers could provide significant societal health benefits.

However, switching distribution of a pharmaceutical fromprescription-only to OTC creates a significant risk that the patientpopulation will be unable to appropriately self-select themselves forsafe use of the pharmaceutical use and then self-medicate using the drugin a responsible manner. The manifestations embodied within theseconcerns include incorrect self-diagnosis, incorrect drug-qualification,unrecognized drug-drug interactions (DDI), unanticipated adverse drugreactions and/or side-effects, improper dosing and/or administration,masking of a disease, addiction, inappropriate drug dependency,substance abuse, and patient delay in seeking necessary medicalattention. Ruiz et al., Current Drug Safety, 5(4):315 (2010).

In order to ensure the safety of OTC distribution of angiotensin IIreceptor blockers, prospective patients must effectively self-selectthemselves for the drug. Recent studies, however, found that manyprospective patients do not pay consistent attention to guidelinesprinted on the packaging of OTC drugs, to ensure safe and responsibleuse. PR Newswire Association, “Americans Should Pay More Attention toOver-the-Counter (OTC) medicine Labels According to New Survey,” October15 (2015) (citing McNeil Consumer Healthcare research). According tothese studies, 40% of prospective patients consider the directions asjust guidelines and 80% of patients do not re-read the label of an OTCmedicine they have used before. Even more troubling, only 58% of mensurveyed found it very important to pay attention to restrictions on anOTC label.

Currently, there are two regulatory pathways for legal marketing of anOTC drug in the United States. In the first pathway, marketing occurs incompliance with an OTC drug monograph, that sets regulatory standardsfor non-prescription drugs that are not covered by human drugapplications, e.g., a New Drug Application (NDA) or Abbreviated New DrugApplication (ANDA). An OTC monograph is created as a result of a threephase OTC drug review by the FDA. In phase I of the review, an advisoryreview panel determines whether ingredients in the proposed OTCcomposition could be generally recognized as safe and effective for usein self-treatment. In the second pathway, marketing occurs under theauthority of an approved product-specific new drug application (NDA), oran abbreviated new drug application (ANDA). In order to support anover-the-counter label for a drug for which regulatory approval is beingsought through an NDA, a consumer research study is required to assessthe consumer's ability to select and deselect themselves as appropriateusers of the drug, based on the proposed labeling for the drug. Oliver,A., Regulatory Rapporteur, 10(3):4-9 (2013), which is incorporated byreference herein.

However, attempts at switching distribution of cardiovascular drugshaving potentially far-reaching benefits for societal health, fromprescription-only to an OTC model, have repeatedly failed, in large partdue to concerns over inappropriate patient selection and medication.Possibly the best documented cases relate to statins used to treat highcholesterol.

For instance, Merck has had at least three applications for sale of overthe counter lovastatin rejected by the FDA, in 2000, 2005, and 2007. In2005, their proposal to permit over the counter sales of lovastatin wasrejected by an expert advisory panel at the FDA in 2005. The panel wasconcerned by a marketing study performed to support the proposal inwhich approximately one third of 3316 customers who were offered thedrug over the counter decided they would purchase the drug. Afterreviewing the data, the panel concluded that 45% of the purchases wouldhave been inappropriate for a variety of reasons, including the age ofthe subject, the subject's lack of knowledge about their condition, andcontraindications associated with their condition. Dyer O., BMJ,330(7484):164 (2005). In 2007, the board again concluded that theability of consumers to appropriately self-select and to adequatelycomply with chronic MEVACOR® therapy without the intervention of aphysician had not been demonstrated. Division of Metabolic and EndocrineDrug Products, 2005, “NDA 21-213 Non-prescription MEVACOR® 20 mg JointAdvisory Committee Meeting.”

Similarly, Pfizer announced in 2011 its intention to switch LIPITOR®from prescription-only to OTC status. Sett OTC bulletin, 16 Nov. 2011,page 7. However, they abandoned their attempt in 2014 when a phase 3“actual use” trial, intended to simulate the OTC use of LIPITOR®(atorvastatin calcium) 10 mg, failed to meet its primary objectives onthe basis that patient compliance with the direction to check theirlow-density lipoprotein cholesterol (LDL-C) level and, after checkingtheir LDL-C level, take appropriate action based on their test resultswas unsatisfactory. Pfizer Inc., “Pfizer Reports Second-Quarter 2015Results,” (2015).

In fact, in the nearly two decades since Bristol-Myers Squibb and Merck& Co first failed in their attempts to switch PRAVACHOL® and lovastatin,respectively, to OTC, a statin has never been granted OTC status in theUnited States. This is despite that nearly 40 million adults in the U.S.who are eligible for cholesterol-lowering medications, under the currentguidelines, are not taking anything.

The information disclosed in this Background section is only forenhancement of understanding of the general background of the inventionand should not be taken as an acknowledgment or any form of suggestionthat this information forms the prior art already known to a personskilled in the art.

SUMMARY

Given the above background, what is needed in the art are systems andmethods for qualifying a human subject for delivery of an angiotensin IIreceptor blocker pharmaceutical composition over-the-counter to lowerblood pressure, e.g., thereby, treating or preventing heart disease.

The present disclosure addresses the need in the art for systems andmethods configured for qualifying a human subject for over-the-counterdelivery of an angiotensin II receptor blocker pharmaceuticalcomposition (e.g., azilsartan medoxomil) in order to treat or preventheart disease, e.g., by lowering blood pressure. In the presentdisclosure, systems and methods are provided for over-the-counterdelivery of an angiotensin II receptor blocker pharmaceuticalcomposition to a subject. Survey results from the subject are runagainst a first plurality of filters. When a filter in the firstplurality is fired, the subject is deemed not qualified for delivery ofthe angiotensin II receptor blocker pharmaceutical composition. Thesurvey results are also run against a second plurality of filters. Whena respective filter in the second plurality is fired, the subject isprovided with a corresponding warning. The method proceeds to afulfillment process when no filter in the first plurality is fired andthe subject has acknowledged each warning associated with each firedfilter in the second plurality of filters. The fulfillment processstores the composition order, communicates a drug facts label for theangiotensin II receptor blocker pharmaceutical composition to thesubject, and authorizes, upon subject confirmation that the label hasbeen read, provision of the angiotensin II receptor blockerpharmaceutical composition to the subject.

Accordingly, one aspect of the present disclosure provides a method forqualifying a subject for over-the-counter delivery of an angiotensin IIreceptor blocker pharmaceutical composition in order to lower the bloodpressure of the subject. The method includes conducting an assessmentsurvey of the subject in order to obtain a variety of assessment surveyresults. In some embodiments, the assessment survey results include oneor more of: whether the subject is pregnant, breastfeeding, or planningto become pregnant, whether the subject is taking a medication thatinteracts (e.g., a pharmacokinetic interaction and/or a pharmacodynamicinteraction) with the angiotensin II receptor blocker pharmaceuticalcomposition, a blood pressure of the subject (e.g., a systolic bloodpressure of the subject and/or a diastolic blood pressure of thesubject), an age of the subject, information required to calculate arisk of atherosclerotic cardiovascular disease for the subject, whetherthe subject has ever had an abnormal electrolyte blood level, andwhether the subject has ever had a kidney problem.

The method also includes running all or a portion of the survey resultsagainst a first plurality of assessment filters of a first categoryclass. When a respective filter in the first plurality of assessmentfilters is fired, the subject is deemed not qualified for delivery ofthe angiotensin II receptor blocker pharmaceutical composition. Themethod is then terminated accordingly without delivery of theangiotensin II receptor blocker pharmaceutical composition to thesubject. In some embodiments, the first plurality of assessment filtersincludes one or more of a pregnancy assessment filter, a druginteraction assessment filter, a blood pressure assessment filter, anage assessment filter, and a pooled cohort equation assessment filter.

The method also includes running all or a portion of the survey resultsagainst a second plurality of assessment filters of a second categoryclass. When a respective filter in the second plurality of assessmentfilters is fired, the subject is provided with a warning correspondingto the respective assessment filter. In some embodiments, the secondplurality of assessment filters includes one or more of an electrolyteblood level assessment filter and a kidney problem assessment filter.However, unlike filters in the first plurality of assessment filters,filters in the second plurality of assessment filters do notautomatically terminate the process without delivery of the angiotensinII receptor blocker pharmaceutical composition to the subject.

The method continues by obtaining acknowledgment from the subject forthe warning issued to the subject by any filter in the second pluralityof reassessment filters. In some embodiments, acknowledgment from thesubject is a written acknowledgement, a verbal acknowledgment, or anelectronic acknowledgment such as an electronic signature.

The method continues by proceeding with a fulfillment process when nofilter in the first plurality of filters has been fired and the subjecthas acknowledged each warning associated with each filter in the secondplurality of filters that was fired.

In some embodiments, the fulfillment process includes storing anindication in a subject profile of an initial order for the angiotensinII receptor blocker pharmaceutical composition, communicating anover-the-counter drug label for the angiotensin II receptor blockerpharmaceutical composition, and authorizing, upon confirmation from thesubject that the over-the-counter drug label has been received and read,provision of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes azilsartan or a pharmaceutically acceptable saltthereof (e.g., azilsartan medoxomil etc.) In some embodiments, theangiotensin II receptor blocker pharmaceutical composition includesazilsartan medoxomil. In some embodiments, the angiotensin II receptorblocker pharmaceutical composition includes candesartan, eprosartan,irbesartan, losartan, olmesartan, telmisartan, or valsartan.

In one aspect, the present disclosure provides a method for qualifying asubject for a re-order (e.g., a subject who was previously qualified toreceive a provision of the angiotensin II receptor blockerpharmaceutical composition) of the angiotensin II receptor blockerpharmaceutical composition (e.g., which is optionally performed inconjunction with a method for qualifying the subject for a first orderof the angiotensin II receptor blocker pharmaceutical composition). Themethod includes a re-fulfillment procedure. The re-fulfillment procedureincludes conducting a reassessment survey of the subject in order toobtain a variety of reassessment survey results. In some embodiments,the reassessment survey results includes one or more of: a bloodpressure of the subject (e.g., a systolic blood pressure of the subjectand/or a diastolic blood pressure of the subject), whether the subjectis one of pregnant, breastfeeding, or planning to become pregnant,whether the subject is taking a medication that interacts with theangiotensin II receptor blocker pharmaceutical composition, whether thesubject has experienced symptoms of hypotension since receiving theirlast provision of the angiotensin II receptor blocker pharmaceuticalcomposition, whether the subject has developed an abnormal electrolyteblood level since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition, and whether the subject hasdeveloped a kidney problem since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition.

The method also includes running all or a portion of the variety ofreassessment survey results against a first plurality of reassessmentfilters of the first category class. When a respective filter in thefirst plurality of reassessment filters is fired, the subject is deemednot qualified for the angiotensin II receptor blocker pharmaceuticalcomposition. Accordingly, the re-fulfillment process is terminatedwithout delivery of the angiotensin II receptor pharmaceuticalcomposition to the subject. In some embodiments, the first plurality ofreassessment filters includes one or more of: a blood pressurereassessment filter, a pregnancy reassessment filter, a drug interactionreassessment filter, a hypotension reassessment filter, an electrolyteblood level reassessment filter, and a kidney problem reassessmentfilter.

In some embodiments, the re-fulfillment procedure includes storing anindication in the subject profile of a re-order for the angiotensin IIreceptor blocker pharmaceutical composition, communicating anover-the-counter drug facts label for the angiotensin II receptorblocker pharmaceutical composition to the subject, and authorizing, uponconfirmation from the subject that the over-the-counter drug facts labelhas been received and read, a re-order provision of the angiotensin IIreceptor blocker pharmaceutical composition to the subject.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary system topology that includes anangiotensin II receptor blocker pharmaceutical compositionover-the-counter (OTC) dispensing device for qualifying a human subjectfor over-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition to lower blood pressure, a data collectiondevice for collecting subject data, one or more user devices associatedwith human subjects, and one or more dispensary destinations fordistributing the angiotensin II receptor blocker pharmaceuticalcomposition over-the-counter, where the above-identified components areinterconnected, optionally through a communications network, inaccordance with an embodiment of the present disclosure.

FIG. 2 illustrates an example device for qualifying a human subject fordelivery of an angiotensin II receptor blocker pharmaceuticalcomposition over-the-counter to lower blood pressure in accordance withvarious embodiments of the present disclosure.

FIGS. 3A and 3B collectively illustrate an example device associatedwith a human subject for qualifying the human subject forover-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition for lowering blood pressure, e.g., therebytreating and/or preventing heart disease, in accordance with anembodiment of the present disclosure, where it will be appreciated thatthe example device of FIG. 3 works in conjunction with the device ofFIG. 2 to perform the methods illustrated in FIGS. 4, 5, 8, and 9 insome embodiments by, for instance, providing the device of FIG. 2 withsurvey results and/or the results of firing filters of the presentdisclosure against such survey results but that, in alternativeembodiments, the device of FIG. 2 performs all the methods of thepresent disclosure and the device of FIG. 3 is not used. In stillfurther alternative embodiments, the device of FIG. 3 performs themethods of the present disclosure and the device of FIG. 2 is not used.

FIGS. 4A, 4B, 4C, 4D, 4E, and 4F collectively provide a flow chart ofprocesses for qualifying a human subject for over-the-counter deliveryof an angiotensin II receptor blocker pharmaceutical composition tolower blood pressure, in accordance with various embodiments of thepresent disclosure.

FIGS. 5A, 5B, 5C, and 5D collectively provide a flow chart of processesfor qualifying a subject for a refill of an over-the-counter delivery ofan angiotensin II receptor blocker pharmaceutical composition to lowerblood pressure, in accordance with various embodiments of the presentdisclosure.

FIGS. 6A, 6B, 6C, 6D, and 6E collectively illustrate a portion of anassessment survey of a subject for obtaining a first plurality ofassessment survey results, in accordance with an embodiment of thepresent disclosure.

FIG. 7 illustrates feedback from a portion of an assessment survey, inaccordance with an embodiment of the present disclosure.

FIGS. 8A, 8B, and 8C collectively illustrate an example method forqualifying a subject for an over-the-counter provision of an angiotensinII receptor blocker pharmaceutical composition, in accordance with anembodiment of the present disclosure.

FIGS. 9A and 9B collectively illustrate an example method for qualifyinga subject for a refill of an over-the-counter provision of anangiotensin II receptor blocker pharmaceutical composition, inaccordance with an embodiment of the present disclosure.

In the figures, reference numbers refer to the same or equivalent partsof the present invention throughout the several figures of the drawing.

DETAILED DESCRIPTION

Hypertension is a growing health problem, in the United States andworldwide. Although hypertension can be effectively treated and/orprevented using established pharmaceutical compositions, access to thesedrugs is hindered by to the requirement for a prescription, as manyindividuals do not have adequate access and/or avoid the healthcaresystem for a variety of reasons. Accordingly, many people are notmanaging their hypertension or conditions related to hypertensionappropriately. While over-the-counter alternatives to these prescriptionpharmaceuticals would increase access to these compositions, therebyimproving population management of hypertension and conditions relatedto hypertension around the world, patients often have difficultyself-selecting themselves for an appropriate over-the-countermedication. Because inappropriate use of these drugs can result inineffective treatment and/or serious side-effects, better methods forselecting for, and treating patients with, other-the-counterhypertension medications are needed. The present disclosure provides,among other aspects, methods, systems, and computer readable media thatsolve these problems.

Reference will now be made in detail to implementations, examples ofwhich are illustrated in the accompanying drawings. In the followingdetailed description of implementations, numerous specific details areset forth in order to provide a thorough understanding of the presentinvention. However, it will be apparent to one of ordinary skill in theart that the present invention may be practiced without these specificdetails.

It will also be understood that, although the terms first, second, etc.may be used herein to describe various elements, these elements shouldnot be limited by these terms. These terms are only used to distinguishone element from another. For example, a first filter could be termed asecond filter, and, similarly, a second filter could be termed a firstfilter, without departing from the scope of the present disclosure. Thefirst filter and the second filter are both filters, but they are notthe same filter.

The terminology used in the present disclosure is for the purpose ofdescribing particular embodiments only and is not intended to belimiting of the invention. As used in the description of the inventionand the appended claims, the singular forms “a,” “an,” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will also be understood that the term “and/or”as used herein refers to and encompasses any and all possiblecombinations of one or more of the associated listed items. It will befurther understood that the terms “comprises” and/or “comprising,” whenused in this specification, specify the presence of stated features,integers, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof.

As used herein, the term “if” may be construed to mean “when” or “upon”or “in response to determining” or “in response to detecting,” dependingon the context. Similarly, the phrase “if it is determined” or “if [astated condition or event] is detected” may be construed to mean “upondetermining” or “in response to determining” or “upon detecting [thestated condition or event]” or “in response to detecting [the statedcondition or event],” depending on the context.

As used herein, the term “over-the-counter” means to provide by retailpurchase, subject to the constraints disclosed herein, but without aprescription or license from a physician or medical practitioner.

As used herein, the term “pharmaceutical compound” refers to anyphysical state of a material. Pharmaceutical compounds include but arenot limited to capsules, tablets, liquids, topical formulations, andinhaled formulations.

As used herein, the term “contraindication” refers to a condition thatmakes a treatment, e.g., over-the-counter use of an angiotensin IIreceptor blocker pharmaceutical composition, inadvisable.Contraindications include physical characteristics of a subject, e.g.,pregnancy or kidney disease, and contemporaneous drug use, e.g.,angiotensin II receptor blocker pharmaceutical composition use. In thepresent context, identification of a contraindication fires a filter ofa first category class, which prevents authorizing provision of anangiotensin II receptor blocker pharmaceutical composition, inaccordance with some implementations of the methods, systems, andsoftware disclosed herein.

As used herein, the term “risk factor” refers to a condition that makesa treatment, e.g., over-the-counter use of an angiotensin II receptorblocker pharmaceutical composition, possibly inadvisable. Risk factorsinclude physical characteristics of a subject, e.g., a blood pressurereading, and contemporaneous drug use, e.g., use of a blood pressuremedication. In the present context, identification of a risk factorfires a filter of a second category class, which prevents authorizingprovision of an angiotensin II receptor blocker pharmaceuticalcomposition without confirmation that the subject has discussed the riskfactor with a medical professional, in accordance with someimplementations of the methods, systems, and software disclosed herein.

As used herein, “drug interactions,” e.g., with an angiotensin IIreceptor blocker pharmaceutical composition, include pharmacokineticdrug interactions and pharmacodynamics drug interactions. Generally, apharmacokinetic drug interaction is an interaction between two drugs(e.g., an angiotensin II receptor blocker and a second drug) that resultin alterations in the absorption, transport, distribution, metabolism,and/or excretion of either drug. Generally, a pharmacokinetic druginteraction is an interaction between two drugs (e.g., an angiotensin IIreceptor blocker and a second drug) that result in a direct change inthe effect or either drug. For a more comprehensive summary ofpharmacokinetic drug interactions and pharmacodynamics druginteractions, see, Cascorbi, I, Dtsch Arztebl Int., 109(33-34):546-55(2012), the content of which is hereby incorporated by reference.

In the context of the present disclosure, classification of a conditionas either a contraindication or a risk factor is specific to aparticular identity and dose of an angiotensin II receptor blockerpharmaceutical composition being authorized for over-the-counter use.Classification of a particular condition, e.g., contemporaneousangiotensin II receptor blocker pharmaceutical composition use, may varybetween different angiotensin II receptor blocker pharmaceuticalcompositions (e.g., it may be classified as a contraindication for afirst angiotensin II receptor blocker, a risk factor for a secondangiotensin II receptor blocker, and/or neither for a third angiotensinII receptor blocker). Likewise, a particular condition may be classifiedas a contraindication for use of a particular angiotensin II receptorblocker at a first over-the-counter dosage, classified as a risk factorfor the same particular angiotensin II receptor blocker at a second(e.g., lower) over-the-counter dosage, and/or classified as neither forthe same particular angiotensin II receptor blocker at a third (e.g.,lowest) over-the-counter dosage.

As used herein, whether a subject “has developed” and/or “hasexperienced” a condition since receiving their last provision of aangiotensin II receptor blocker refers to both conditions that are newto the subject, i.e., a condition that the subject did not have at thetime they received their last provision of the angiotensin II receptorblocker, and conditions that have been newly diagnosed, regardless ofwhether the condition existed when the subject received their lastprovision of the angiotensin II receptor blocker, i.e., a condition thatthe subject was not aware of when they received their last provision ofthe angiotensin II receptor blocker.

The term “alkyl,” by itself or as part of another substituent, means,unless otherwise stated, a straight or branched chain, or cyclichydrocarbon radical, or combination thereof, which may be fullysaturated, mono- or polyunsaturated and can include di-, tri- andmultivalent radicals, having the number of carbon atoms designated (e.g.C₁-C₁₀ means one to ten carbons). Examples of saturated hydrocarbonradicals include, but are not limited to, groups such as methyl, ethyl,n-propyl, isopropyl, n-butyl, t-butyl, isobutyl, sec-butyl, cyclohexyl,(cyclohexyl)methyl, cyclopropylmethyl, homologs and isomers of, forexample, n-pentyl, n-hexyl, n-heptyl, n-octyl, and the like. Anunsaturated alkyl group is one having one or more double bonds or triplebonds. Examples of unsaturated alkyl groups include, but are not limitedto, vinyl, 2-propenyl, crotyl, 2-isopentenyl, 2-(butadienyl),2,4-pentadienyl, 3-(1,4-pentadienyl), ethynyl, 1- and 3-propynyl,3-butynyl, and the higher homologs and isomers. The term “alkyl,” unlessotherwise noted, is also meant to optionally include those derivativesof alkyl defined in more detail below, such as “heteroalkyl.” Alkylgroups that are limited to hydrocarbon groups are termed “homoalkyl”.Exemplary alkyl groups include the monounsaturated C₉₋₁₀, oleoyl chainor the diunsaturated C_(9-10, 12-13) linoeyl chain.

The terms “cycloalkyl” and “heterocycloalkyl,” by themselves or incombination with other terms, represent, unless otherwise stated, cyclicversions of “alkyl” and “heteroalkyl”, respectively. Additionally, forheterocycloalkyl, a heteroatom can occupy the position at which theheterocycle is attached to the remainder of the molecule. Examples ofcycloalkyl include, but are not limited to, cyclopentyl, cyclohexyl,1-cyclohexenyl, 3-cyclohexenyl, cycloheptyl, and the like. Furtherexemplary cycloalkyl groups include steroids, e.g., cholesterol and itsderivatives. Examples of heterocycloalkyl include, but are not limitedto, 1-(1,2,5,6-tetrahydropyridyl), 1-piperidinyl, 2-piperidinyl,3-piperidinyl, 4-morpholinyl, 3-morpholinyl, tetrahydrofuran-2-yl,tetrahydrofuran-3-yl, tetrahydrothien-2-yl, tetrahydrothien-3-yl,1-piperazinyl, 2-piperazinyl, and the like.

Each of the above terms (e.g., “alkyl,” “heteroalkyl,” and “cycloalkyl”)are meant to optionally include both substituted and unsubstituted formsof the indicated species. Exemplary substituents for these species areprovided below.

Substituents for the alkyl and heteroalkyl radicals (including thosegroups often referred to as alkylene, alkenyl, heteroalkylene,heteroalkenyl, alkynyl, cycloalkyl, heterocycloalkyl, cycloalkenyl, andheterocycloalkenyl) are generically referred to as “alkyl groupsubstituents,” and they can be one or more of a variety of groupsselected from, but not limited to: H, substituted or unsubstituted aryl,substituted or unsubstituted heteroaryl, substituted or unsubstitutedheterocycloalkyl, —OR′, ═O, ═NR′, —NR′R″, —SR′, halogen, —SiR′R″R′″,—OC(O)R′, —C(O)R′, —CONR′R″, —OC(O)NR′R″, —NR″C(O)R′, —NR′—C(O)NR″R′″,—NR″C(O)₂R′, —NR—C(NR′R″R′″)═NR″″, NR C(NR′R″)═NR′″, —S(O)R′, —S(O)₂R′,—S(O)₂NR′R″, NRSO₂R′, —CN and —NO₂ in a number ranging from zero to (2m′+1), where m′ is the total number of carbon atoms in such radical. R′,R″, R′″ and R″″ each preferably independently refer to hydrogen,substituted or unsubstituted heteroalkyl, substituted or unsubstitutedaryl, e.g., aryl substituted with 1-3 halogens, substituted orunsubstituted alkyl, alkoxy or thioalkoxy groups, or arylalkyl groups.When a compound of the invention includes more than one R group, forexample, each of the R groups is independently selected as are each R′,R″, R′″ and R″″ groups when more than one of these groups is present.When R′ and R″ are attached to the same nitrogen atom, they can becombined with the nitrogen atom to form a 5-, 6-, or 7-membered ring.For example, —NR′R″ is meant to include, but not be limited to,1-pyrrolidinyl and 4-morpholinyl. From the above discussion ofsubstituents, one of skill in the art will understand that the term“alkyl” is meant to include groups including carbon atoms bound togroups other than hydrogen groups, such as haloalkyl (e.g., —CF₃ and—CH₂CF₃) and acyl (e.g., —C(O)CH₃, —C(O)CF₃, —C(O)CH₂OCH₃, and thelike). These terms encompass groups considered exemplary “alkyl groupsubstituents,” which are components of exemplary “substituted alkyl” and“substituted heteroalkyl” moieties.

As used herein, the term “heteroatom” includes oxygen (O), nitrogen (N),sulfur (S) and silicon (Si), boron (B) and phosphorous (P).

The term “salt(s)” includes salts of the compounds prepared by theneutralization of acids or bases, depending on the particular ligands orsubstituents found on the compounds described herein. When compounds ofthe present invention contain relatively acidic functionalities, baseaddition salts can be obtained by contacting the neutral form of suchcompounds with a sufficient amount of the desired base, either neat orin a suitable inert solvent. Examples of base addition salts includesodium, potassium calcium, ammonium, organic amino, or magnesium salt,or a similar salt. Examples of acid addition salts include those derivedfrom inorganic acids like hydrochloric, hydrobromic, nitric, carbonic,monohydrogencarbonic, phosphoric, monohydrogenphosphoric,dihydrogenphosphoric, sulfuric, monohydrogensulfuric, hydriodic, orphosphorous acids, and the like, as well as the salts derived fromrelatively nontoxic organic acids like acetic, propionic, isobutyric,butyric, maleic, malic, malonic, benzoic, succinic, suberic, fumaric,lactic, mandelic, phthalic, benzenesulfonic, p-tolylsulfonic, citric,tartaric, methanesulfonic, and the like. Certain specific compounds ofthe present invention contain both basic and acidic functionalities thatallow the compounds to be converted into either base or acid additionsalts. Hydrates of the salts are also included.

It is understood that, in any compound described herein having one ormore chiral centers, if an absolute stereochemistry is not expresslyindicated, then each center may independently be of R-configuration orS-configuration or a mixture thereof. Thus, the compounds providedherein may be enantiomerically pure or be stereoisomeric mixtures. Inaddition, it is understood that, in any compound described herein havingone or more double bond(s) generating geometrical isomers that can bedefined as E or Z, each double bond may independently be E or Z amixture thereof. Likewise, it is understood that, in any compounddescribed, all tautomeric forms are also intended to be included.

In one aspect of the present disclosure, a survey (e.g., an assessmentsurvey and/or a reassessment survey) of a subject is conducted to obtainsurvey results in order to determine if the subject qualifies for anover-the-counter (OTC) angiotensin II receptor blocker (e.g., AGTR1,AGTR2) pharmaceutical composition for lowering blood pressure, e.g.,thereby, treating or preventing an atherosclerotic cardiovasculardisease. The survey results are used as the basis for running filters ofa first category class. If the triggering conditions of any of thefilters in the first category class are fired, the subject does notqualify for the OTC angiotensin II receptor blocker pharmaceuticalcomposition. In some embodiments, the survey results are also used asthe basis for running filters of a second category class. If thetriggering conditions of any of the filters in the second category classare fired, the subject is provided with warning messages associated withthe respective filters of the second category class that have beenfired. If none of the filters in the first category class are fired andthe subject successfully addresses the warning messages associated withthe respective filters of the second category class that have been fireda fulfillment process is initiated for OTC delivery of the angiotensinII receptor blocker pharmaceutical composition.

FIG. 1 illustrates an example of an integrated system 48 for conductingone or more surveys (e.g., an assessment survey and/or a reassessmentsurvey) of one or more subjects in order to qualifying the subjects forOTC delivery of an angiotensin II receptor blocker pharmaceuticalcomposition. The integrated system 48 includes one or more connecteduser devices 102 (e.g., first user device 102-1, second user device102-2, . . . , Q^(th) user device 102-Q). The user devices 102 areconfigured for entering survey data and making requests for theangiotensin II receptor blocker pharmaceutical composition. The system48 also includes one or more dispensary destination devices 104 that isconfigured to receive instructions in order to provide the angiotensinII receptor blocker pharmaceutical composition to qualifying subjects.Furthermore, the system 48 includes an angiotensin II receptor blockerpharmaceutical composition over-the-counter (OTC) dispensing device 250and one or more data collection devices 200 that are configured forcollecting subject data.

Throughout the present disclosure, the data collection device 200 andthe angiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250 will be referenced as separate devices solely forpurposes of clarity. That is, the disclosed functionality of the datacollection device 200 and the disclosed functionality of the angiotensinII receptor blocker pharmaceutical composition OTC dispensing device 250are contained in separate devices as illustrated in FIG. 1. However, itwill be appreciated that, in fact, in some embodiments, the disclosedfunctionality of the data collection device 200 and the disclosedfunctionality of the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 are contained in a single device.

With the integrated system 48, survey results from the subjects are runagainst a first plurality of filters, such as a first plurality ofassessment filters (e.g., filter 216-1, filter 216-2, filter 216-4,etc.) and/or a first plurality of reassessment filters (e.g., filter216-6, filter 216-7, etc.). When a filter in the first respectiveplurality of filters (e.g., filter 216) is fired for a respectivesubject, the respective subject is deemed not qualified for theangiotensin II receptor blocker pharmaceutical composition. In someembodiments, the survey results are also run against a second pluralityof filters (e.g., filter 222-1, filter 222-2, filter 222-6, etc.) When arespective filter in the second respective plurality is fired for arespective subject, the respective subject is provided with a warning(e.g., filter warning 226) associated with the respective filter. Insome embodiments, the survey results are run against the first pluralityof filters and the second plurality of filters concurrently. In someembodiments, the survey results are run against the first plurality offilters and then against the second plurality of filters. For instance,in some embodiments the survey results are obtained and then run againstthe plurality of filters. However, the present disclosure is not limitedthereto. In some embodiments, each survey result is run against acorresponding filter prior to a subsequent survey result being obtained,thereby preventing a user from unnecessarily providing survey results inaccordance with a determination that the user is not qualified for theangiotensin II receptor blocker pharmaceutical composition.

As used herein, unless expressly stated otherwise, a survey refers toboth an assessment survey and/or a reassessment survey. For instance, insome embodiments a first survey result corresponds to an assessmentsurvey, whereas in other embodiments a first survey results correspondsto a reassessment survey, without departing from the scope of thepresent disclosure.

The method enabled by the integrated system 48 proceeds to a fulfillmentprocess, or similarly a refulfillment process, when no filter in thefirst respective plurality of filters fires and the subject hasacknowledged, or otherwise successfully addressed, each warningassociated with each filter in the second respective plurality offilters that fired. As part of the fulfillment process, or refulfillmentprocess, the composition order is stored (e.g., in a user profile 234associated with the subject to receive the drug), a drug facts label(e.g., drug facts label 230) for the angiotensin II receptor blocker iscommunicated to the qualifying subject. Upon subject confirmation thatthe label has been read, authorization is granted to dispense theangiotensin II receptor blocker.

Referring to FIG. 1, the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 qualifies a subject forover-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition to lower blood pressure. To accomplish theabove, the data collection device 200, which is in electricalcommunication with the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250, receives survey results (e.g.,assessment survey results and/or reassessment survey results)originating from one or more user devices 102 that are associated withcorresponding subjects. In some embodiments, the data collection device200 receives such survey results directly from the user devices 102. Forinstance, in some embodiments the data collection device 200 receivesthis data wirelessly through radio-frequency (RF) signals. In someembodiments, such signals are in accordance with an 802.11 (Wi-Fi),Bluetooth, or ZigBee standard. In some embodiments, the data collectiondevice 200 receives such data directly, analyzes the data, and passesthe analyzed data to the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250.

In some embodiments, the data collection device 200 and/or theangiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250 is not proximate to the subject and/or does nothave wireless capabilities or such wireless capabilities are not usedfor the purpose of acquiring survey results. In such embodiments, acommunication network 106 may be used to survey questions (e.g., surveyquestions 208, 212) from the angiotensin II receptor blockerpharmaceutical composition OTC dispensing device 250 to user devices 102and the answers to such survey questions from the user devices 102 tothe data collection device 200 and/or the angiotensin II receptorblocker pharmaceutical composition OTC dispensing device 250. Further,in some embodiments the communication network 106 is used to communicateauthorization to dispense the angiotensin II receptor blocker surveyquestions from the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 to dispensary destination devices104.

Examples of networks 106 include, but are not limited to, the World WideWeb (WWW), an intranet and/or a wireless network, such as a cellulartelephone network, a wireless local area network (LAN) and/or ametropolitan area network (MAN), and other devices by wirelesscommunication. The wireless communication optionally uses any of aplurality of communications standards, protocols and technologies,including but not limited to Global System for Mobile Communications(GSM), Enhanced Data GSM Environment (EDGE), high-speed downlink packetaccess (HSDPA), high-speed uplink packet access (HSUPA), Evolution,Data-Only (EV-DO), HSPA, HSPA+, Dual-Cell HSPA (DC-HSPDA), long termevolution (LTE), near field communication (NFC), wideband code divisionmultiple access (W-CDMA), code division multiple access (CDMA), timedivision multiple access (TDMA), Bluetooth, Wireless Fidelity (Wi-Fi)(e.g., IEEE 802.11a, IEEE 802.11ac, IEEE 802.11ax, IEEE 802.11b, IEEE802.11g and/or IEEE 802.11n), voice over Internet Protocol (VoW),Wi-MAX, a protocol for e-mail (e.g., Internet message access protocol(IMAP) and/or post office protocol (POP)), instant messaging (e.g.,extensible messaging and presence protocol (XMPP), Session InitiationProtocol for Instant Messaging and Presence Leveraging Extensions(SIMPLE), Instant Messaging and Presence Service (IMPS)), and/or ShortMessage Service (SMS), or any other suitable communication protocol,including communication protocols not yet developed as of the filingdate of the present disclosure.

Of course, other topologies of the system 48 are possible. For instance,rather than relying on a communications network 106, the one or moreuser devices 102 and the one or more dispensary destination devices 104may communicate directly to the data collection device 200 and/or theangiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250. Further, the data collection device 200 and/orthe angiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250 may constitute a portable electronic device, aserver computer, or in fact constitute several computers that are linkedtogether in a network, be a virtual machine in a cloud computingcontext, be a container in a cloud computer context, or a combinationthereof. As such, the exemplary topology shown in FIG. 1 merely servesto describe the features of an embodiment of the present disclosure in amanner that will be readily understood to one of skill in the art.

Turning to FIG. 2 with the foregoing in mind, an exemplary angiotensinII receptor blocker pharmaceutical composition OTC dispensing device 250configured for determining whether a subject is qualified for OTCdelivery of an angiotensin II receptor blocker is depicted. Referring toFIG. 2, in typical embodiments, the angiotensin II receptor blockerpharmaceutical composition OTC dispensing device 250 includes one ormore computers. For purposes of illustration in FIG. 2, the angiotensinII receptor blocker pharmaceutical composition OTC dispensing device 250is represented as a single computer that includes all of thefunctionality for qualifying a human subject for over-the-counterdelivery of an angiotensin II receptor blocker pharmaceuticalcomposition to lower blood pressure. However, the present disclosure isnot limited thereto. In some embodiments, the functionality forqualifying a human subject for over-the-counter delivery of anangiotensin II receptor blocker pharmaceutical composition to lowerblood pressure is spread across any number of networked computers and/orresides on each of several networked computers, is hosted on one or morevirtual machines at a remote location accessible across thecommunications network 106, and/or is hosted on one or more containersat a remote location accessible across the communications network 106.One of skill in the art will appreciate that any of a wide array ofdifferent computer topologies are used for the present disclosure andall such topologies are within the scope of the present disclosure.

The angiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250 of FIG. 2 is configured to conduct an assessmentsurvey (e.g., using assessment module 252 to perform an initialqualification of the subject for provision of a angiotensin II receptorblocker pharmaceutical composition) and/or a reassessment survey (e.g.,using reassessment module 254 to perform a re-qualification of thesubject for provision of a angiotensin II receptor blockerpharmaceutical composition). The assessment survey (e.g., theassessment) includes a variety of questions 208, 212 associated withassessment filters 216, 222 within a first plurality of assessmentfilters of the first filter category class 214 and a second plurality ofassessment filters in the second filter category class 220,respectively. Answers to the questions in the assessment survey receivedby the device 250 are run against one or more assessment filters of afirst category class 216-1 and/or, in some embodiments, one or moreassessment filters of a second category class 220-1 within the first andsecond pluralities of assessment filters 214-1 and 216-1, respectively.Similarly, the reassessment survey (e.g., the re-assessment) alsoincludes a variety of questions 208, 212 associated with reassessmentfilters 216, 222 within a first plurality of reassessment filters of afirst category class 214-2 and/or, in some embodiments, a secondplurality of reassessment filters of a second category class 220-2,respectively. Answers to the questions in the reassessment surveyreceived by the device 250 are run against one or more reassessmentfilters of a first category class 216-2 and reassessment filters of asecond category class 220-2, e.g., within the first and secondpluralities of reassessment filters, respectively. Reassessment filters216 of the first filter category class 214 are configured to terminatethe qualification process when fired. Reassessment filters 222 of thesecond filter category class 220 are configured to provide the subjectwith a warning associated with a corresponding survey question. In otherwords, the device of FIG. 2 is configured to accumulate results from asurvey (e.g., survey questions 208 and survey questions 212 of anassessment survey module 252 and/or a reassessment survey module 545)and run the results against corresponding filters (e.g., assessmentfilters and/or reassessment filters, respectively) in order to determineif a subject is qualified for OTC delivery of an angiotensin II receptorblocker pharmaceutical composition.

In the present disclosure, a plurality of filters refers to a series, orset, or filters in either the first filter category class or the secondcategory class. For instance, in some embodiments, a plurality offilters of the first filter category class 214 can include any subset offilters 216 of the first filter category class. As an example, in someembodiments a plurality of filters of the first category class includesfilters 216-1, 216-2, 216-3, . . . , 216-i, or any combination thereof.Similarly, a plurality of filters of the second filter category class220 can include any set of filters 222 of the second filter categoryclass. Moreover, in some embodiments a plurality of filters of thesecond category class includes filters 222-1, 222-2, 222-3, . . . ,222-i, or any combination thereof. However, the present disclosure isnot limited thereto. For instance, in some embodiments filters of thefirst category class are categorized according to which survey thefilter is associated with (e.g., filters of the first category class arecategorized by assessment filters and/or reassessment filters, filtersof the second category class are categorized by assessment filtersand/or reassessment filters).

Continuing to refer to FIG. 2, in some embodiments, the dispensingdevice 250 includes one or more processing units (CPU's) 274, a networkor other communications interface 284, a memory 192 (e.g., random accessmemory), one or more magnetic disk storage and/or persistent devices 290optionally accessed by one or more controllers 288, one or morecommunication busses 213 for interconnecting the aforementionedcomponents, a user interface 278, the user interface 278 including adisplay 282 and input 280 (e.g., a keyboard, a keypad, a touch screen,etc.), and a power supply 276 for powering the aforementionedcomponents. In some embodiments, data in memory 192 is seamlessly sharedwith non-volatile memory 290 using known computing techniques such ascaching. In some embodiments, memory 192 and/or memory 290 includes massstorage that is remotely located with respect to the central processingunit(s) 274. In other words, some data stored in memory 192 and/ormemory 290 may in fact be hosted on computers that are external to theangiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250 but that can be electronically accessed by theangiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250 over an Internet, intranet, or other form ofnetwork or electronic cable (illustrated as element 106 in FIG. 2) usingnetwork interface 284.

In some embodiments, the memory 192 of the angiotensin II receptorblocker pharmaceutical composition OTC dispensing device 250 stores oneor more of:

-   -   an operating system 202 that includes procedures for handling        various basic system services;    -   an assessment module 252 for qualifying a subject for an initial        over-the-counter delivery of an angiotensin II receptor blocker        pharmaceutical composition to lower blood pressure, e.g.,        treating or preventing heart disease, by communicating        assessment survey questions, obtaining results therefrom, and        applying the results to qualifying assessment filters, the        assessment module including:        -   a first filter category class 214-1, including assessment            filters 216 (e.g., a first plurality of assessment filters),            each respective assessment filter 216 in the first filter            category class 214-1 associated with one or more assessment            survey questions 208 and one or more triggering conditions            218;        -   a second filter category class 220-1, including assessment            filters 222 (e.g., a second plurality of assessment            filters), each respective assessment filter 222 in the            second filter category class 220-1 associated with one or            more assessment survey questions 208, triggering conditions            224, and warnings 226;    -   a fulfillment module 228-1 for executing a fulfillment process        when no assessment filter 216 in the first filter category class        214-1 has been fired for a subject and the subject has        acknowledged each warning 226 associated with each assessment        filter 222 in the second filter category class 220-1 that was        fired as a result of answers by the subject to the assessment        survey questions 208, where the fulfillment process includes        communicating an over-the-counter drug facts label 230 for the        angiotensin II receptor blocker pharmaceutical composition to        the subject and receiving confirmation from the subject that the        over-the-counter drug facts label has been received and read;    -   a reassessment module 254 for qualifying a subject for a        subsequent over-the-counter delivery of an angiotensin II        receptor blocker pharmaceutical composition to lower blood        pressure, e.g., treating or preventing heart disease, by        communicating reassessment survey questions, obtaining results        therefrom, and applying the results to qualifying reassessment        filters, the reassessment module including:        -   a first filter category class 214-2, including reassessment            filters 216 (e.g., a first plurality of reassessment            filters), each respective reassessment filter 216 in the            first filter category class 214-2 is associated with one or            more reassessment survey questions 208 and one or more            triggering conditions 218;        -   a second filter category class 220-2, including reassessment            filters 222 (e.g., a second plurality of filters), each            respective filter 222 in the second filter category class            220-2 is associated with one or more survey questions 212,            triggering conditions 224, and warnings 226;    -   a re-fulfillment module 228-2 for executing a re-fulfillment        process when no reassessment filter 216 in the first filter        category class 214-2 has been fired for a subject and the        subject has acknowledged each warning 226 associated with each        reassessment filter 222-2 in the second filter category class        220 that was fired as a result of answers by the subject to the        reassessment survey questions 212, where the re-fulfillment        process includes communicating an over-the-counter drug facts        label 230 for the angiotensin II receptor blocker pharmaceutical        composition to the subject and receiving confirmation from the        subject that the over-the-counter drug facts label has been        received and read;    -   a subject profile data store 232 comprising a user profile 234        for each of a plurality of subjects, each respective user        profile 234 including information (e.g., shipping information,        billing information, biometric information, etc.) about a        corresponding subject in the plurality of subjects, an initial        order date and/or destination 236, and any re-order date and/or        the destination 238 for the angiotensin II receptor blocker        pharmaceutical composition made by the corresponding subject        using the angiotensin II receptor blocker pharmaceutical        composition OTC dispensing device 250;    -   an adverse event module 242 for identifying and aggregating        records of adverse events associated with a plurality of        subjects, e.g., corresponding to the firing of a reassessment        filter 216 in the first filter category class 214-2 during a        re-fulfillment process;    -   a reimbursement module 240 for determining eligibility and/or        communicating an insurance claim associated with delivery of the        angiotensin II receptor blocker, e.g., based on insurance        information stored in a respective user profile 234.

In some embodiments, the assessment module 252, the reassessment module254, and/or the fulfillment module 228 is accessible within any browser(e.g., phone, tablet, laptop/desktop, or smartwatch). In someembodiments, the assessment module 252, reassessment module 254, and/orfulfillment module 228 run on native device frameworks, and is availablefor download onto a user device 102 running an operating system 202 suchas Android, iOS, or WINDOWS.

In some implementations, one or more of the above identified dataelements or modules (e.g., assessment module 252, fulfillment module228-1, etc.) of the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 for qualifying a human subject forover-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition to lower blood pressure are stored in one ormore of the previously described memory devices, and correspond to a setof instructions for performing a function described above. Theabove-identified data, modules or programs (e.g., sets of instructions)need not be implemented as separate software programs, procedures ormodules, and thus various subsets of these modules may be combined orotherwise re-arranged in various implementations. In someimplementations, the memory 192 and/or 290 optionally stores a subset ofthe modules and data structures identified above. Furthermore, in someembodiments the memory 192 and/or 290 stores additional modules and datastructures not described above.

In some embodiments, an angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 for qualifying a human subject forover-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition to lower blood pressure is a smart phone(e.g., an iPhone, Blackberry, etc.), a laptop, a tablet computer, adesktop computer, a smart watch, or another form of electronic device(e.g., a gaming console, a kiosk, a virtual reality system, etc.). Insome embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 is not mobile. In someembodiments, the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 is mobile.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition OTC dispensing device 250 is not a smart phone but rather isa tablet computer, desktop computer, emergency vehicle computer, orother form or wired or wireless networked device. In the interest ofbrevity and clarity, only a few of the possible components of theangiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250 are shown in FIG. 2 in order to better emphasizethe additional software modules that are installed on the angiotensin IIreceptor blocker pharmaceutical composition OTC dispensing device 250.

FIG. 3 provides a description of a user device 102 that can be used withthe present disclosure. The user device 102 illustrated in FIG. 3 hasone or more processing units (CPU's) 374, peripherals interface 370,memory controller 368, a network or other communications interface 384,a memory 392 (e.g., random access memory), a user interface 378, theuser interface 378 including a display 382 and input 380 (e.g., akeyboard, a keypad, a touch screen), an optional accelerometer 317, anoptional GPS 319, optional audio circuitry 372, an optional speaker 360,an optional microphone 362, one or more optional intensity sensors 364for detecting intensity of contacts on the user device 102 (e.g., atouch-sensitive surface such as a touch-sensitive display system 382 ofthe user device 102), an optional input/output (I/O) subsystem 366, oneor more optional optical sensors 373, one or more communication busses313 for interconnecting the aforementioned components, and a powersupply 376 for powering the aforementioned components.

In some embodiments, the input 380 is a touch-sensitive display, such asa touch-sensitive surface. In some embodiments, the user interface 378includes one or more soft keyboard embodiments. The soft keyboardembodiments may include standard (e.g., QWERTY) and/or non-standardconfigurations of symbols on the displayed icons.

The user device 102 illustrated in FIG. 3 optionally includes, inaddition to accelerometer(s) 317, a magnetometer (not shown) and a GPS319 (or GLONASS or other global navigation system) receiver forobtaining information concerning the location and orientation (e.g.,portrait or landscape) of the user device 102 and/or for determining anamount of physical exertion by the subject.

It should be appreciated that the user device 102 illustrated in FIG. 3is only one example of a multifunction device that may be used forperforming a survey (e.g., assessment module 252) in order to qualifyfor over-the-counter delivery of a angiotensin II receptor blockerpharmaceutical composition to lower blood pressure, and that the userdevice 102 optionally has more or fewer components than shown,optionally combines two or more components, or optionally has adifferent configuration or arrangement of the components. The variouscomponents shown in FIG. 3 are implemented in hardware, software,firmware, or a combination thereof, including one or more signalprocessing and/or application specific integrated circuits.

Memory 392 of the user device 102 illustrated in FIG. 3 optionallyincludes high-speed random access memory and optionally also includesnon-volatile memory, such as one or more magnetic disk storage devices,flash memory devices, or other non-volatile solid-state memory devices.Access to memory 392 by other components of the angiotensin II receptorblocker pharmaceutical composition OTC dispensing device 250, such asCPU(s) 374 is, optionally, controlled by the memory controller 368. Insome embodiments, the memory 392 of the user device 102 illustrated inFIG. 3 optionally includes:

-   -   an operating system 302 that includes procedures for handling        various basic system services;    -   the assessment module 252 described above in conjunction with        the angiotensin II receptor blocker pharmaceutical composition        OTC dispensing device 250;    -   the first category class 214 described above in conjunction with        the angiotensin II receptor blocker pharmaceutical composition        OTC dispensing device 250 further comprising a pregnancy        assessment filter 216-1, a drug interaction assessment filter        216-2, a blood pressure assessment filter 216-3, an age        assessment filter 216-4, and a pooled cohort equation assessment        filter 216-5; and    -   the second category class 220 described above in conjunction        with the angiotensin II receptor blocker pharmaceutical        composition OTC dispensing device 250 comprising an electrolyte        blood level assessment filter 222-1, and a kidney problem        assessment filter 222-2;

In some embodiments, the optional accelerometer 317, optional GPS 319,and/or magnetometer (not shown) of the user device 102 or suchcomponents are used to recommend to qualifying subjects one or moresuitable destinations for delivery of the angiotensin II receptorblocker pharmaceutical composition over-the-counter. In someembodiments, the GPS 319 is used to determine if a subject isgeographically restricted for OTC delivery of the angiotensin IIreceptor pharmaceutical composition. Geographical restrictions includebut are not limited to a subject residing outside of delivery orshipping regions, marketing restrictions, and/or government regulations.

The peripherals interface 370 can be used to couple input and outputperipherals of the device to CPU(s) 374 and memory 392. The one or moreprocessors 374 run or execute various software programs and/or sets ofinstructions stored in memory 392, such as the survey module 204, toperform various functions for the user device 102 and to process data.

In some embodiments, the peripherals interface 370, CPU(s) 374, andmemory controller 368 are, optionally, implemented on a single chip. Insome other embodiments, they are implemented on separate chips.

RF (radio frequency) circuitry of network interface 384 receives andsends RF signals, also called electromagnetic signals. In someembodiments, the survey module 252/254, survey questions 208/212,answers to survey questions 208/212, and/or the over-the-counter drugfacts label 230 are communicated to the subject device 102 using this RFcircuitry. In some embodiments, the RF circuitry 384 converts electricalsignals to/from electromagnetic signals and communicates withcommunications networks and other communications devices and/or the datacollection device 200 and/or the angiotensin II receptor blockerpharmaceutical composition OTC dispensing device 250 via theelectromagnetic signals. The RF circuitry 384 optionally includeswell-known circuitry for performing these functions, including but notlimited to an antenna system, an RF transceiver, one or more amplifiers,a tuner, one or more oscillators, a digital signal processor, a CODECchipset, a subscriber identity module (SIM) card, memory, and so forth.RF circuitry 384 optionally communicates with the communication network106. In some embodiments, the circuitry 384 does not include RFcircuitry and, in fact, is connected to the network 106 through one ormore hard wires (e.g., an optical cable, a coaxial cable, or the like).

In some embodiments, the audio circuitry 372, the optional speaker 360,and the optional microphone 362 provide an audio interface between thesubject and the user device 102. The audio circuitry 372 receives audiodata from the peripherals interface 370, converts the audio data toelectrical signals, and transmits the electrical signals to the speaker360. The speaker 360 converts the electrical signals to human-audiblesound waves. In some embodiments, the speaker 360 converts theelectrical signals to human-inaudible sound waves. The audio circuitry372 also receives electrical signals converted by the microphone 362from sound waves. The audio circuitry 372 converts the electrical signalto audio data and transmits the audio data to peripherals interface 370for processing. Audio data is, optionally, retrieved from and/ortransmitted to the memory 392 and/or the RF circuitry 384 by theperipherals interface 370.

In some embodiments, the power supply 376 optionally includes a powermanagement system, one or more power sources (e.g., battery, alternatingcurrent (AC)), a recharging system, a power failure detection circuit, apower converter or inverter, a power status indicator (e.g., alight-emitting diode (LED)) and any other components associated with thegeneration, management and distribution of power in portable devices.

In some embodiments, the user device 102 optionally also includes one ormore optical sensors 373. The optical sensor(s) 373 optionally includecharge-coupled device (CCD) or complementary metal-oxide semiconductor(CMOS) phototransistors. The optical sensor(s) 373 receive light fromthe environment, projected through one or more lens, and converts thelight to data representing an image. The optical sensor(s) 373optionally capture still images and/or video. In some embodiments, anoptical sensor is located on the back of the user device 102, oppositethe display 382 on the front of the user device 102, so that the input380 is enabled for use as a viewfinder for still and/or video imageacquisition. In some embodiments, another optical sensor 373 is locatedon the front of the user device 102 so that the subject's image isobtained (e.g., to verify the health, condition, or identity of thesubject as part of qualifying the subject for over-the-counter deliveryof an angiotensin II receptor blocker pharmaceutical composition tolower blood pressure), to help diagnose a subject's condition remotely,or to acquire visual physiological measurements of the subject, etc.)

As illustrated in FIG. 3, the user device 102 preferably includes anoperating system 302 that includes procedures for handling various basicsystem services. The operating system 302 (e.g., iOS, DARWIN, RTXC,LINUX, UNIX, OS X, WINDOWS, or an embedded operating system such asVxWorks) includes various software components and/or drivers forcontrolling and managing general system tasks (e.g., memory management,storage device control, power management, etc.) and facilitatescommunication between various hardware and software components.

In some embodiments, the user device 102 is a smart phone or a smartwatch. In other embodiments, the user device 102 is not a smart phone ora smart watch but rather is a tablet computer, a desktop computer, anemergency vehicle computer, or other form or wired or wireless networkeddevice. In the interest of brevity and clarity, only a few of thepossible components of the user device 102 are shown in FIG. 3 in orderto better emphasize the additional software modules that are installedon the user device 102.

While the system 48 disclosed in FIG. 1 can work standalone, in someembodiments it can also be linked with an electronic medical recordssystem to exchange information in any way.

Now that details of a system 48 for qualifying a human subject forover-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition to lower blood pressure have been disclosed,details regarding methods (e.g., an assessment method 400 of FIG. 4and/or a reassessment method 500 of FIG. 5), including processes andfeatures to be performed by the system, in accordance with an embodimentof the present disclosure, are disclosed with reference to FIGS. 4 and5, respectively. In some embodiments, such processes and features of thesystem 48 are carried out by the assessment module 252, reassessmentmodule 254, fulfillment module 228-1, and/or re-fulfillment module 228-2illustrated in FIGS. 2 and 3. In some embodiments, the assessment module252, reassessment module 254, fulfillment module 228-1, and/orre-fulfillment module 228-1 are a single software module.

FIG. 4 illustrates method 400 for qualifying (402) a human subject forover-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition for lowering blood pressure, e.g., thereby,treating and/or preventing heart disease, using a computer system suchas an angiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250. As illustrated in FIG. 2, the angiotensin IIreceptor blocker pharmaceutical composition OTC dispensing device (e.g.,device 250) includes one or more processors (e.g., processor 274) and amemory (e.g., memory 192 and/or 290). The memory stores non-transitoryinstructions that, when executed by the one or more processors, performa method.

Referring to block 404 of FIG. 4A, in some embodiments the angiotensinII receptor blocker pharmaceutical composition has a structure ofstructure (I):

Accordingly, R¹ is a group represented by the formula:

Moreover, R², R³, R⁴, R⁵, R⁶, R⁷, and R⁸ are each independently ahydrogen atom or a C1-6 alkyl, or a salt thereof.

Referring to blocks 406 through 410 of FIG. 4A, in some embodiments theangiotensin II receptor blocker pharmaceutical composition includes anactive ingredient that is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate,or a pharmaceutically acceptable salt thereof.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes an active ingredient that is azilsartan, or apharmaceutically acceptable prodrug thereof. In some embodiments, theactive ingredient is azilsartan medoxomil, or a pharmaceuticallyacceptable salt thereof.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes one or more active ingredient selected fromcandesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan,valsartan, or a pharmaceutically acceptable salt thereof. In someembodiments, the angiotensin II receptor blocker pharmaceuticalcomposition is a prodrug. As used herein, a prodrug refers to apharmaceutical composition that includes a biologically inactivecompound that is metabolized in vivo to generate the active form of thedrug. For instance, in some embodiments the prodrug angiotensin IIreceptor blocker pharmaceutical composition includes azilsartan,candesartan, losartan, or olmesartan. Additional information regardingthese angiotensin II receptor blocker active ingredients is described inFarnham et al., 2000, “Angiotensin II receptor antagonists,” The Lancet,335(9204), pg. 594, the content of which is hereby incorporated byreference, in its entirety, for all purposes.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 7,572,920,entitled “Benzimidazole derivative and use as a II receptor antagonist,”as an active ingredient. In some embodiments, the angiotensin IIreceptor blocker pharmaceutical composition includes any compounddisclosed in U.S. Pat. No. 7,157,584, entitled “Benzimidazole derivativeand use thereof,” as an active ingredient.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 5,656,560,entitled “Angiotensin II receptor blocking compositions,” as an activeingredient. In some embodiments, the angiotensin II receptor blockerpharmaceutical composition includes any compound disclosed in U.S. Pat.No. 5,185,351, entitled “Imidazolyl-alkenoic acids useful as angiotensinII receptor antagonists,” as an active ingredient.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 5,270,317,entitled “N-substituted heterocyclic derivatives, their preparation andthe pharmaceutical compositions in which they are present,” as an activeingredient. In some embodiments, the angiotensin II receptor blockerpharmaceutical composition includes any compound disclosed in U.S. Pat.No. 5,994,348, entitled “Pharmaceutical compositions containingirbesartan,” as an active ingredient. In some embodiments, theangiotensin II receptor blocker pharmaceutical composition includes anycompound disclosed in U.S. Pat. No. 6,342,247, entitled “Pharmaceuticalcompositions containing irbesartan,” as an active ingredient.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 5,210,079,entitled “Treatment of chronic renal failure with imidazoleangiotensin-II receptor antagonists,” as an active ingredient. In someembodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 5,608,075,entitled “Polymorphs of losartan and the process for the preparation ofform II of losartan,” as an active ingredient.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 5,616,599,entitled “Angiotensin II antagonist 1-biphenylmethylimidazole compoundsand their therapeutic use,” as an active ingredient. In someembodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 6,878,703,entitled “Pharmaceutical composition,” as an active ingredient.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 5,591,762,entitled “Benzimidazoles useful as angiotensin-II antagonists,” as anactive ingredient. In some embodiments, the angiotensin II receptorblocker pharmaceutical composition includes any compound disclosed inU.S. Pat. No. 6,358,986, entitled “Polymorphs of telmisartan,” as anactive ingredient. In some embodiments, the angiotensin II receptorblocker pharmaceutical composition includes any compound disclosed inU.S. Pat. No. 7,998,953, entitled “Use of inhibitors of therenin-angiotensin system,” as an active ingredient.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes any compound disclosed in U.S. Pat. No. 5,399,578,entitled “Acyl compounds,” as an active ingredient. In some embodiments,the angiotensin II receptor blocker pharmaceutical composition includesany compound disclosed in U.S. Pat. No. 5,559,111, entitled“δ-amino-γ-hydroxy-ω-aryl-alkanoic acid amides,” as an activeingredient. In some embodiments, the angiotensin II receptor blockerpharmaceutical composition includes any compound disclosed in U.S. Pat.No. 5,972,990, entitled “Methods for reducing risk of repeat myocardialinfarction and increasing survival in heart attack victims,” as anactive ingredient. In some embodiments, the angiotensin II receptorblocker pharmaceutical composition includes any compound disclosed inU.S. Pat. No. 6,294,197, entitled “Solid oral dosage forms ofvalsartan,” as an active ingredient. In some embodiments, theangiotensin II receptor blocker pharmaceutical composition includes anycompound disclosed in U.S. Pat. No. 6,395,728, entitled “Method oftreatment and pharmaceutical composition,” as an active ingredient.

The disclosures of each of U.S. Pat. Nos. 7,572,920, 7,157,584,5,656,560, 5,185,351, 5,270,317, 5,994,348, 6,342,247, 5,210,079,5,608,075, 5,616,599, 6,878,703, 5,591,762, 6,358,986, 7,998,953,5,399,578, 5,559,111, 5,972,990, 6,294,197, and 6,395,728, are herebyincorporated by reference, in their entireties, for all purposes, andspecifically for the chemical structures of angiotensin II receptorblocker molecules disclosed therein.

Referring to block 412 of FIG. 4A, in some embodiments, the lowering ofblood pressure is to treat and/or prevent heart disease. Typically, thistreatment and/or prevention of heart disease is accomplished by areduction in systemic vascular resistance and/or arterial pressure. Forinstance, in some embodiments this treatment and/or prevention of heartdisease is accomplished by selectively blocking the binding ofangiotensin II to the ΔT₁ receptor in many tissues. Blockage of theangiotensin II receptor inhibits the negative regulatory feedback ofangiotensin II on renin secretion.

As described in detail below, method 400 includes eliciting medicalinformation about the user, which is used to qualify or disqualify thesubject for an over-the-counter provision of the angiotensin II receptorblocker pharmaceutical composition. However, in some embodiments, beforebeginning to elicit this information, the system registers the subjectand/or ensures that the subject is prepared to proceed through thequalification process. For example, in some embodiments, the systemfirst determines whether the subject has already registered, waspreviously qualified, and/or previously received a provision of theover-the-counter provision of the angiotensin II receptor blockercomposition.

When the subject has not yet registered with the system, device 250registers the subject as a new user and creates a corresponding userprofile (e.g., regardless of whether the subject previously received aprescription provision of the angiotensin II receptor). The system thenperforms an assessment method (e.g., assessment method 400) to qualifythe patient for a first over-the-counter provision of the angiotensin IIreceptor blocker pharmaceutical composition.

When the subject already has a user profile 234, e.g., as verified witha user password, the device registers the user as a returning customer.When the returning subject has previously received an over-the-counterprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, the system performs a reassessment method (e.g.,reassessment method 500) to qualify the subject for a subsequentprovision. When the returning subject has not previously received anover-the-counter provision of the angiotensin II receptor blockerpharmaceutical composition (e.g., because they did not previouslyqualify or choose not to purchase the composition after beingqualified), the system performs an assessment method (e.g., assessmentmethod 400) to qualify the patient for a first over-the-counterprovision of the angiotensin II receptor blocker pharmaceuticalcomposition.

In some embodiments, where a new user does not already have a userprofile 234 (e.g., the subject has not previously been qualified for anover-the-counter provision of the angiotensin II receptor blocker) thedevice registers the user as a new user and creates a corresponding userprofile, regardless of whether the subject previously received aprescription provision of the angiotensin II receptor blocker. In someembodiments, when a new user has not previously been qualified for anover-the-counter provision of the angiotensin II receptor blocker, buthas received a prescription for the angiotensin II receptor blocker, thedevice will consider the new user a returning user and will perform are-order qualification (e.g., via method 500), rather than an initialqualification (e.g., via method 400).

In some embodiments, prior to eliciting medical information from thesubject, the system prompts (e.g., 802 of FIG. 8A) to confirm that theyhave adequate privacy to provide sensitive medical information and/orthat they are in possession of the medical information required tocomplete the qualification process. For example, in some embodiments thesystem prompts (e.g., 804 of FIG. 8A) the user to confirm that they haveknowledge of their blood pressure, cardiovascular history, etc.

Blocks 414 Through 416.

Referring to block 414 of FIG. 4A, the method includes conducting anassessment survey of the subject. By way of the assessment survey, aplurality of assessment survey results to survey questions 208, 212(e.g., one or more of the survey questions set forth in Table 1) areobtained (e.g., the device 250 transmits one or more assessment surveyquestions to the user, prompting a response, and then receives aresponse to the one or more assessment survey questions back from thesubject). In some embodiments, the assessment survey results includesome or all of the characteristics listed in Table 1. For example, insome embodiments, the plurality of assessment survey results includes 2,3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or all21 of the characteristics listed in Table 1. In one embodiment, theplurality of assessment survey results includes at least characteristics1-8 as provided in Table 1. In one embodiment, the plurality ofassessment survey results includes at least characteristics 1-15 asprovided in Table 1.

It will be appreciated that the survey questions 208, 212 and filters216, 222 applied to the assessment survey answers thereof may varydepending upon the angiotensin II receptor blocker pharmaceuticalcomposition being distributed. This varying is due to differences in thecontraindication profiles of the various the angiotensin II receptorblocker pharmaceutical compositions, e.g., due to different drug-druginteractions, routes of drug clearance, etc. of the different theangiotensin II receptor blocker pharmaceutical compositions. Forexample, co-administration of a potassium supplement with a single oraldose of azilsartan medoxomil had no significant effect on thepharmacokinetics of azilsartan medoxomil. However, co-administration ofa potassium supplement with valsartan resulted in increases in serumcreatinine. See, Novartis Pharmaceuticals Corp., 2017,“Diovan—Highlights of Prescribing Information,” Print. As such, in someembodiments, an assessment survey, or similarly a reassessment survey,qualifying a subject for OTC use of valsartan may ask whether thesubject consumes a potassium supplement or similar salt in their diet,while a similar survey qualifying a subject for OTC use of azilsartanmedoxomil may not.

Referring to block 416, and as further illustrated in FIG. 8, in someembodiments the assessment survey results include whether the subject isone of pregnant, breastfeeding, or planning to become pregnant (e.g.,responsive to a survey question 208 that is associated with and/orapplied to (805) a pregnancy assessment filter 216-1 of a first categoryclass), whether the subject is taking a medication that interacts withthe angiotensin II receptor blocker pharmaceutical composition (e.g.,responsive to a survey question 208 that is associated with and/orapplied to (810) a drug interaction assessment filter 216-2 of a firstcategory class), a systolic blood pressure of the subject (e.g.,responsive to a survey question 208 that is associated with and/orapplied to (815, 865) a blood pressure assessment filter 216-3 of afirst category class, and/or a pooled cohort equation assessment filter216-5 of a first category class), a diastolic blood pressure of thesubject (e.g., responsive to a survey question 208 that is associatedwith and/or applied to (815) a blood pressure assessment filter 216-3 ofa first category class), an age of the subject (e.g., responsive to asurvey question 208 that is associated with and/or applied to (830) anage assessment filter 216-4 of a first category class), informationrequired to calculate a risk of atherosclerotic cardiovascular diseasefor the subject (e.g., responsive to a survey question 208 that isassociated with and/or applied to (825 through 865) a pooled cohortequation assessment filter 216-5 of a first category class), whether thesubject has ever had an abnormal electrolyte blood level (e.g.,responsive to a survey question 212 that is associated with and/orapplied to (875) an abnormal electrolyte blood level assessment filter222-2 of a second category class), and whether the subject has ever hada kidney problem (e.g., response to a survey question 212 that isassociated with and/or applied to (870) a kidney problem assessmentfilter 222-1 of a second category class).

In some embodiments, the assessment survey includes questions thatelicit responses providing some or all of the characteristics listed inTable 1. In some embodiments, the assessment survey includes questionscorresponding to each of the assessment survey results required for themethods described herein. In other embodiments, the assessment surveyincludes questions corresponding to only a subset of the assessmentsurvey results required for the methods described herein. For instance,in some embodiments the subset of assessment survey results correspondsto a respective angiotensin II receptor blocker (e.g., a first subsetcorresponds to azilsartan, a second subset corresponds to olmesartan,etc.). In such embodiments, one or more assessment survey resultsrequired for the methods described herein are acquired through othermeans (e.g., upon registration/subscription for a service associatedwith qualifying the subject for over-the-counter medication, from ahealthcare provider, from a prior survey, from a database associatedwith a pharmacy, from an electronic health record associated with thesubject, from the subject profile data store 232, etc.) For example, insome embodiments, the subject provides a personal medical identificationassociated with an insurer, a hospital, or other healthcare provider andinformation about the subject required for the methods described herein,e.g., one or more survey results, is acquired from a preexistingdatabase associated with the personal medical identification (e.g., ablood pressure measurement determined for the subject).

TABLE 1 Example Medical Information Elicited from Assessment SurveyQuestions Result Example Characteristics 1 whether the subject pregnantor breastfeeding 2 whether the subject is taking a medication thatinteracts with the angiotensin II receptor blocker pharmaceuticalcomposition 3 a systolic blood pressure of the subject 4 a diastolicblood pressure of the subject 5 an age of the subject 6 informationrequired to calculate a risk of atherosclerotic cardiovascular diseasefor the subject 7 whether the subject has ever had an abnormalelectrolyte blood level 8 whether the subject has ever had a kidneyproblem 9 a gender of the subject 10 a race of the subject 11 a bloodpressure medication status of the subject 12 a smoking status of thesubject 13 a total cholesterol level of the subject 14 a high densitylipoprotein cholesterol level of the subject 15 a diabetes status of thesubject 16 whether the subject has ever had an atheroscleroticcardiovascular history including an atherosclerotic cardiovascular eventor a heart procedure 17 whether the subject has ever had liver problems18 whether the subject is taking a potassium supplement or a saltsubstitute that includes potassium 19 whether the subject is takingcolesevelam 20 whether the subject has ever had a heart failure 21whether the subject is allergic to the angiotensin II receptor blockerpharmaceutical composition

It is contemplated that, in some embodiments, any one or more of thesurvey questions 208, 212 provided in Table 1 will not be included inthe assessment survey (e.g., will not be used for the assessment). Forexample, in some embodiments, a characteristic associated with aparticular survey question will be informative when qualifying a subjectfor one particular angiotensin II receptor blocker but not for anotherangiotensin II receptor blocker. For instance, in some embodiments anassessment survey question is queried for azilsartan medoxomilqualifying surveys but not for telmisartan qualifying surveys (e.g., theassessment survey question is not relevant for telmisartan). The skilledartisan will recognize that different angiotensin II receptor blockerscarry different risk and drug interaction profiles. Accordingly,assessment survey information required for qualifying a subject foraccess to one angiotensin II receptor blocker with a known adverse druginteraction may not be necessary for qualifying the same subject foraccess to a second angiotensin II receptor blocker.

Accordingly, it is contemplated that the assessment survey questions 208include any subset of survey results provided in Table 1. For brevity,all possible combinations of the survey questions 208, 212 provided inTable 1 are not specifically delineated here. However, the skilledartisan will easily be able to envision any particular subset of thesurvey questions 208, 212 provided in Table 1. Likewise, the skilledartisan may know of other survey questions, not provided in Table 1,that may be combined with any subset of the survey questions provided inTable 1 to form the assessment survey questions used in the methodsdescribed herein.

In some embodiments, the assessment survey and/or the reassessmentsurvey is conducted by transmitting a plurality of respective questionsto the subject, e.g., some or all of the respective survey questions,and receiving answers to the plurality of respective survey questionsbefore applying any of the answers to respective filters. For example,with reference to the workflow in FIG. 8, the device transmits questionsrelating to all of the assessment filters of the first category class,all of the assessment filters of the second category class, or all ofthe assessment filters in the workflow (e.g., as a virtual assessmentsurvey where all of the questions are displayed in a single userinterface, or as a series of questions displayed in consecutive userinterfaces). After receiving answers to all of the assessment surveyquestions, the device then applies the answers to all of the assessmentfilters (e.g., sequentially or concurrently) to determine whether thesubject is qualified to receive a provision of the angiotensin IIreceptor blocker pharmaceutical composition. In alternative embodiments,the device transmits questions relating to just those assessment filtersof the first category class for which it could not obtain answers to thequestions from an electronic database associated with the subject, suchas electronic health record of the subject, and just those assessmentfilters of the second category class it could not obtain answers to thequestions from an electronic database associated with the subject (e.g.,as a virtual assessment survey where such unanswered questions aredisplayed in a single user interface, or as a series of questionsdisplayed in consecutive user interfaces). After receiving answers toall of the survey questions, the device then applies the answers to allof the filters (e.g., sequentially or concurrently) to determine whetherthe subject is qualified to receive provision of the angiotensin IIreceptor blocker pharmaceutical composition.

In some embodiments, the assessment survey and/or the reassessmentsurvey is conducted in a serial fashion, e.g., by transmitting a firstquestion or a first group of survey questions (e.g., associated with asingle respective filter) to the subject, receiving an answer to thesingle survey question or small group of survey questions, and applyingthe answer or answers to a filter, prior to transmitting a secondquestion or second group of questions to the subject. For example, withreference to the workflow in FIG. 8, in some embodiments the devicetransmits a first assessment question to the subject, relating to thebody electrolyte levels in the blood of the subject (e.g., question 650‘Are you pregnant or breastfeeding, think you may be pregnant, or planto become pregnant?’ in FIG. 6C). After receiving the answer to thesurvey question (e.g., ‘yes or no’), the device applies the answer to anassessment pregnancy filter (805). If the assessment pregnancy filter isfired (e.g., in response to a “yes” answer), the device terminates(895-1) the process, and optionally provides the user with a messagerelating to why they are being denied a provision of the angiotensin IIreceptor blocker pharmaceutical composition, a suggestion forfollowing-up with a medical professional (e.g., as illustrated in FIG.6B, when the survey answers indicate that the subject has had abnormalbody salt levels in their blood (875), the device optionally terminatesthe process (880) and advises that the subject seek guidance from aprofessional medical practitioner), and/or a suggestion to make alifestyle change (e.g., as illustrated in FIG. 8A, when the surveyanswers indicate that the subject has slightly elevated blood pressure(815-2), the device terminates the process (895-3) and advises that thesubject improve their diet or exercise routine which is consistent withcurrent blood pressure treatment guidelines), to treat or manage theirblood pressure.

In some embodiments, one or more survey questions are not transmitted toa respective subject in accordance with a result to a previous surveyquestion. For instance, in some embodiments where the ASCVD riskcalculation is bypassed by an indication that the subject has a historyof ASCVD (e.g., bypass mechanism 863 in FIG. 8C), if an assessmentsurvey result indicates that a subject has a history of ASCVD (e.g., atstep 820 in FIG. 8A), one or more assessment survey questions related toa pooled cohort equation assessment filter are bypassed (not transmittedto the user) because the ASCVD pooled cohort filter can be bypassed.

In some embodiments, the assessment survey includes one or morequestions that elicit responses that provide some or all of thecharacteristics listed in Table 1. In some embodiments, the assessmentsurvey includes questions corresponding to each of the survey resultsrequired for the methods described herein. In other embodiments, theassessment survey includes questions corresponding to only a subset ofthe survey results required for the methods described herein. In suchembodiments, the other survey results required for the methods describedherein are acquired through other means (e.g., upon registration and/orsubscription for a service that is associated with qualifying thesubject for over-the-counter medication, from a healthcare provider,from a prior survey (e.g., from an assessment survey if a subject istaking a reassessment survey), from a database associated with apharmacy, etc.) For example, in some embodiments, the subject provides apersonal medical identification (e.g., identifier) associated with aninsurer, a hospital, and/or another healthcare provider and informationabout the subject required for the methods described herein, e.g., oneor more survey results, is acquired from a preexisting databaseassociated with the personal medical identification (e.g., a lastcholesterol or blood pressure measurement determined for the subject).The same applies to the reassessment survey module 254 and correspondingresults applied to the assessment survey module 252.

As described in detail below, the methods disclosed herein include stepsof applying information collected about a subject to a plurality offilters designed to identify contraindications—which render the subjectunsuitable for treatment with the angiotensin II receptor blockergenerally or at least in the self-care environment (i.e., withoutphysician supervision)—and risk factors—which render administration ofthe angiotensin II receptor blocker unnecessarily risky without furtherphysician consultation. The contraindication and risk factors describedherein are non-exhaustive, as the skilled artisan will know of otherpossible contraindications or risk factors for a particular angiotensinII receptor blocker pharmaceutical composition. Moreover, as medicalresearch progresses, new contraindications or risk factors may bediscovered. Or, similarly, the classification of existingcontraindications or risk factors may change with additional medicalresearch or consideration. For example, a factor considered to be acontraindication may be reclassified as a risk factor, over time, orvice-a-versa.

Further, a contraindication for one angiotensin II receptor blockerpharmaceutical composition may only be a risk factor, or neither, for adifferent angiotensin II receptor blocker pharmaceutical composition,for example, based on different mechanisms, interaction,pharmacokinetic, and/or pharmacodynamics properties of the respectiveactive ingredients. Similarly, a factor that is a contraindication orrisk factor for a particular angiotensin II receptor blockerpharmaceutical composition when administered at one dose, e.g., a high,moderate, or low dose, may be classified differently when administeredat a different dose. For example, a contraindication for an angiotensinII receptor blocker pharmaceutical composition administered at a highdose may only be a risk factor, or neither, when administered at a lowdose. This is particularly true when the risk factor, e.g., a druginteraction, changes the bioavailability of the active ingredient by acertain factor, such that the bioavailability following high doseadministration, but not low dose administration, would increase beyond asafe threshold.

Blocks 418-452.

Referring to block 418 of FIG. 4B, all or a portion of the assessmentsurvey results are run against a first plurality of assessment filtersof a first category class 214. As previously described, the firstplurality of assessment filters includes a subset of filters 216 of thefirst filter category class 214. When a respective filter in the firstplurality of assessment filters is fired (e.g., in accordance with adetermination that a survey result indicates that a triggering condition218 has been met), the subject is deemed not qualified for delivery ofthe angiotensin II receptor blocker pharmaceutical composition and themethod is terminated without delivery of the angiotensin II receptorblocker pharmaceutical composition.

In some embodiments, e.g., when the method is terminated withoutdelivery of the angiotensin II receptor blocker pharmaceuticalcomposition, the subject is prevented from attempting to requalify forthe angiotensin II receptor blocker pharmaceutical composition for apredetermined period of time. This prevents the subject from abusing thesystems and methods of the present disclosure.

Referring to blocks 420-470 of FIGS. 4B through 4E, specific assessmentfilters 216 in the first plurality of assessment filters and theirexemplary triggering conditions 218 that cause the correspondingassessment filter to fire are described.

In some embodiments, the first plurality of assessment filters of thefirst category class 214 includes some or all of the filters 216 listedin Table 2. For example, in some embodiments, the first plurality ofassessment filters results includes 2, 3, 4, or all 5 of the filterslisted in Table 2.

TABLE 2 Example Assessment Filters of the First Category Class FilterExample Criteria 1a a pregnancy assessment filter 2a a drug interactionassessment filter 3a a blood pressure assessment filter 4a an ageassessment filter 5a a pooled cohort equation assessment filter 6a aliver disease assessment filter

In one embodiment, the first plurality of assessment filters includes atleast filters 1a-5a as provided in Table 2. In some embodiments, wherethe particular angiotensin II receptor blocker pharmaceuticalcomposition is contraindicated for administration to patients with liverdisease, the first plurality of assessment filters further includesfilter 6a.

It is contemplated that, in some embodiments, any one or more of theassessment filters 216 provided in Table 2 will not be included in thefirst plurality of assessment filters. For example, in some embodiments,a characteristic associated with a particular survey result will beinformative if qualifying a subject for one particular angiotensin IIreceptor blocker but not for another angiotensin II receptor blocker,e.g., filter 6a. In some implementations, one or more of the assessmentfilters 216 provided in Table 2 is implemented as a second type filter,as described below, which only provides a warning to the user and/orrequires the user confirm they have spoken to a physician about theunderlying risk.

Accordingly, it is contemplated that in some embodiments the firstplurality of assessment filters includes any sub-set of filters 216provided in Table 2. Likewise, in some embodiments the skilled artisanmay know of other filters 216, not are provided in Table 2, which may becombined with any subset of the filters 216 provided in Table 2 to formthe first plurality of assessment filters and corresponding results usedin the methods described herein. For brevity, all possible combinationsof the assessment filters 216 provided in Table 2 are not specificallydelineated here.

Referring to blocks 420-422 of FIG. 4B, in some embodiments the firstplurality of assessment filters includes a pregnancy filter (e.g.,pregnancy assessment filter 216-1 in FIG. 3 and/or filter 1a in Table2). In some embodiments, the pregnancy assessment filter is configuredto be fired at least when the first plurality of assessment surveyresults indicates that the subject is pregnant or the subject isbreastfeeding. In some embodiments, the pregnancy assessment filter isalso configured to be fired when the subject is planning on becomingpregnant. When the pregnancy assessment filter is fired, the subject isnot permitted to obtain the angiotensin II receptor blockerpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing provision of the angiotensin II receptorblocker pharmaceutical composition to the subject). For example, in someembodiments the device transmits prompt 654, as illustrated in FIG. 6C,to the subject and the device applies the answer provided by the subjectto the pregnancy assessment filter. If the subject's answer indicatesthat they are pregnant, they are planning on being pregnant, they arebreastfeeding, or they are planning to breastfeeding, the pregnancyassessment filter is fired and the method is terminated withoutauthorizing provision of the angiotensin II receptor blockerpharmaceutical composition to the subject. In some embodiments, thedevice transmits a message explaining why authorization was denied.

Referring to blocks 424 through 430 of FIG. 4B, in some embodiments, thefirst plurality of assessment filters includes a drug interaction filter(e.g., drug interaction assessment filter 216-2 in FIG. 3 and/or filter2a in Table 2). The drug interaction assessment filter is configured tobe fired at least when the first plurality of assessment survey resultsindicates that the subject is taking a medication that interacts withthe angiotensin II receptor blocker pharmaceutical composition. When thedrug interaction assessment filter is fired, the device transmits awarning corresponding to the drug interaction assessment filter, andrequires the user to acknowledge the warning before authorizing aprovision of the angiotensin II receptor blocker pharmaceuticalcomposition.

In some embodiments, a drug capable of firing the drug interactionassessment filter includes a lithium medication or supplement. Forinstance, in some embodiments (e.g., embodiments in which theangiotensin II receptor blocker pharmaceutical composition includesazilsartan medoxomil, increases in the serum lithium concentrationsand/or lithium toxicity have been observed if the angiotensin IIreceptor blocker is administered with a lithium medication.

In some embodiments, a drug capable of firing the drug interactionassessment filter includes a non-steroidal anti-inflammatory drug(NSAID). In some embodiments, a non-steroidal anti-inflammatory drugcapable of firing the drug interaction assessment filter includesibuprofen. In some embodiments, a non-steroidal anti-inflammatory drugcapable of firing the drug interaction assessment filter includesnaproxen.

In some embodiments, a drug capable of firing the drug interactionassessment filter includes a blood pressure medication. For instance, insome embodiments the drug interaction assessment filter is fired if theassessment survey results indicate that the subject is taking amedication for treating and/or preventing high blood pressure. In someembodiments, these high blood pressure medications include a diureticmedication such as a water pill.

The identity (e.g., active ingredient(s), inactive ingredient(s), or acombination thereof) of one or more drugs that are capable of triggeringthe drug interaction assessment filter vary from one angiotensin IIreceptor blocker to another angiotensin II receptor blocker. The skilledartisan will know of one or more drugs that interact with oneangiotensin II receptor blocker but not another. Inclusion of a drugwithin the drug interaction assessment filter is dependent upon theidentity and/or the dosage of the angiotensin II receptor blockerpharmaceutical composition being authorized for over-the-counter use.

In some embodiments, a drug that interacts with an angiotensin IIreceptor blocker pharmaceutical composition is included within a filter222 in the second filter category class 220, rather than within druginteraction assessment filter 216 of the first filter category class214. For example, according to some implementations, a particular drugincluded in drug-interaction assessment filter 216 (e.g., as a riskfactor) for a first angiotensin II receptor blocker pharmaceuticalcomposition, but included in a filter in the second plurality ofassessment filters (e.g., as a contraindication) for a secondangiotensin II blocker pharmaceutical composition. However, a personskilled in the art will know whether to include a certain drug withindrug interaction assessment filter 216 or as a separate filter 222 inthe second plurality of assessment filters, based on the severity andrisk of the drug interaction with the particular identity and dosage ofthe angiotensin II receptor blocker being authorized forover-the-counter use.

Referring to blocks 432 through 442 of FIGS. 4B and 4C, in someembodiments the first plurality of assessment filters includes a bloodpressure assessment filter (e.g., blood pressure assessment filter 216-3in FIG. 3 and/or filter 3a in Table 2). In some embodiments, the bloodpressure assessment filter is configured to be fired at least when theplurality of assessment survey results indicates that the subject is nothypertensive or the subject has severe hypertension. If the bloodpressure assessment filter is fired, the subject is not permitted toobtain the angiotensin II receptor blocker pharmaceutical compositionover-the-counter (e.g., the method is terminated without authorizingprovision of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject).

In some embodiments, the blood pressure assessment filter is fired whenthe plurality of assessment survey results indicates that the systolicblood pressure of the subject is less than a floor systolic pressure anda diastolic blood pressure of the subject is greater than a floordiastolic blood pressure. In some embodiments, the floor systolicpressure is 131 mm Hg and the floor diastolic pressure is 81 mm Hg. Insome embodiments, the floor systolic pressure is 130 mm Hg and the floordiastolic pressure is 80 mm Hg. In some embodiments, the floor systolicpressure is 129 mm Hg and the floor diastolic pressure is 79 mm Hg. Forinstance, in some embodiments the blood pressure assessment filter isfired if the assessment survey results indicate that the subject is nothypertension (e.g., a systolic blood pressure of at least 130 mm Hg anda diastolic blood pressure of at least 80 mm Hg). In some embodiments,the blood pressure assessment filter is fired if the assessment surveyresults indicate that the subject has severe hypertension (e.g., asystolic blood pressure of at least 140 mm Hg or a diastolic bloodpressure of at least 90 mm Hg). Furthermore, in some embodiments if theplurality of assessment survey results indicate that the subject haselevated blood pressure but is not hypertension, the blood pressurefilter is fired. Accordingly, advice is transmitted to the subject tomanage their blood pressure by eating healthy and exercising. In someembodiments, if the plurality of assessment survey results indicate thatthe subject has stage two (II) hypertension, the blood pressureassessment filter is fired. Accordingly, advice is transmitted to thesubject to discuss taking a prescription-strength blood pressuremedication with a professional medical practitioner. Furthermore, insome embodiments if the plurality of assessment survey results indicatethat the subject is in hypertension crises, the blood pressureassessment filter is fired. Accordingly, advice is transmitted to thesubject to seek emergency medical attention. In some embodiments, theblood pressure cutoffs (e.g., a blood pressure floor and/or ceiling)defining when the blood pressure filter is fired and when the bloodpressure filter is not fired are set according to a set of healthcareguidelines, which may change over time, and/or vary on ajurisdiction-by-jurisdiction basis. For example, in the United States,the American College of Cardiology and the American Heart Associationcollaborated to provide guidance on management of high blood pressure.Whelton P K, et al., J Am Coll Cardiol., S0735-1097(17)41519-1 (2017),the contents of which are hereby expressly incorporated by reference.These guidelines change over time as medical research and advances intreatment better inform management of high blood pressure.

In some embodiments, e.g., when the plurality of assessment surveyresults indicate that the subject has elevated blood pressure but is nothypertensive (e.g., a systolic blood pressure in between 120 and 129 mmHg and a diastolic blood pressure less than 80 mm Hg), the first bloodpressure filter is fired, and advice is transmitted to the subject tomanage their blood pressure by eating healthy and exercising. In someembodiments, e.g., when the plurality of assessment survey resultsindicate that the subject has hypertension stage two (e.g., a systolicblood pressure greater than or equal to 140 mm Hg or a diastolic bloodpressure greater than or equal to 90 mm Hg), the first blood pressurefilter is fired and advice is transmitted to the subject to visit adoctor to discuss taking a prescription-strength blood pressuremedication. In some embodiments, e.g., when the plurality of assessmentsurvey results indicate that the subject is in hypertension crisis(e.g., a systolic blood pressure greater than 180 mm Hg and/or adiastolic blood pressure greater than 120 mm Hg), the first bloodpressure filter is fired, and advice is transmitted to the subject toseek emergency medical attention.

Referring to blocks 444 and 446 of FIG. 4C, in some embodiments thefirst plurality of assessment filters includes an age assessment filter(e.g., age filter 216-4 in FIG. 3 and/or filter 4a in Table 2). In someembodiments, the age assessment filter is fired when the plurality ofassessment survey results indicates that the subject is too young toreceive the angiotensin II receptor blocker pharmaceutical composition.For instance, in some embodiments an age in which the subject is tooyoung to receiving the angiotensin II receptor blocker pharmaceuticalcomposition is determined by on a jurisdiction-by-jurisdiction basis(e.g., a first subject in one geographic region is of age to receive theangiotensin II receptor blocker while a second subject in anothergeographic region of the same age is not permitted to receiving theangiotensin II receptor blocker). In some embodiments, the ageassessment filter is fired when the plurality of assessment surveyresults indicates that the subject is less than sixteen years old. Insome embodiments, the age assessment filter is fired when the pluralityof assessment survey results indicates that the subject is less thaneighteen years old. In some embodiments, the age assessment filter isfired when the plurality of assessment survey results indicates that thesubject is less than twenty-one years old. If the age assessment filteris fired, the subject is not permitted to obtain the angiotensin IIreceptor blocker pharmaceutical composition pharmaceutical compositionover-the-counter (e.g., the method is terminated without authorizingprovision of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject).

In some embodiments, the age filter is fired when the plurality ofassessment survey results indicates that the subject has an age forwhich a risk of an atherosclerotic cardiovascular disease (ASCVD) eventcannot be calculated according to a predictive algorithm (e.g., a10-year risk estimate for a hard ASCVD event using the pooled cohortequations provided in Goff, D C Jr. et al., Circulation (2013). Forexample, in some embodiments, the age assessment filter is fired whenthe plurality of assessment survey results indicates that the subject isless than forty years old, which would provide an incalculable riskusing the equations in Goff et al. Similarly, in some embodiments theage assessment filter is fired when the plurality of assessment surveyresults indicates that the subject is older than seventy-nine years old.

Referring to blocks 448 through 458 of FIGS. 4C and 4D, in someembodiments the first plurality of assessment filters includes a pooledcohort equation assessment filter (e.g., pooled cohort equation filter216-5 in FIG. 3 and/or filter 5a in Table 2). In some embodiments, thepooled cohort equation assessment filter incorporates the gender of thesubject, the race of the subject, the age of the subject, the bloodpressure medication status of the subject, the total cholesterol levelof the subject, the HDL cholesterol count of the subject, the systolicblood pressure of the subject, the smoking status of the subject (e.g.,whether the subject currently smokes or has smoked in the past), and thediabetes status of the subject (e.g., whether the subject has Type-1diabetes, Type-2 diabetes, etc.) to derive a risk for atheroscleroticcardiovascular disease (e.g., a risk for experiencing an atheroscleroticcardiovascular disease (ASCVD) event within a certain timeframe, such aswithin five or ten years). In some embodiments, the pooled cohortequation also incorporates a familial history of premature heart orstroke (e.g., a history of heart attack or stroke before the age offorty-five, fifty, fifty-five, sixty, etc.). In some embodiments, thepooled cohort equation incorporates a high sensitive quantification ofc-reactive protein (hsCRP) level of the subject. Nevertheless, in someembodiments the pooled cohort equation assessment filter is fired if theplurality of assessment survey results indicate that the subject has arisk for atherosclerotic cardiovascular that is either below a floorthreshold of risk or the subject has an incalculable risk foratherosclerotic cardiovascular disease. If the pooled cohort equationfilter is fired, the subject is not permitted to obtain the angiotensinII receptor blocker pharmaceutical composition pharmaceuticalcomposition over-the-counter (e.g., the method is terminated withoutauthorizing provision of the angiotensin II receptor blockerpharmaceutical composition to the subject).

In some embodiments, the pooled cohort equation assessment filter isconfigured to be fired at least when the plurality of assessment surveyresults indicates that, despite having hypertension stage 1 (e.g., asystolic blood pressure of 130 to 139 mm HG or a diastolic bloodpressure of 80 to 89 mm Hg) the subject has a risk for atheroscleroticdisease that falls below a minimum risk threshold (e.g., the subjectdoes not have a high enough risk of having an ASCVD event to justifytaking a angiotensin II receptor blocker pharmaceutical composition). Insome embodiments, the risk for the atherosclerotic cardiovasculardisease calculated using the pooled cohort equation is a lifetime risk,a 5-year risk, or a 10-year risk. Furthermore, in some embodiments therisk for the atherosclerotic cardiovascular disease using the pooledcohort equation is in a range of a year to a lifetime (e.g., 100 years,80 years, 50 years, etc.). In some embodiments, the pooled cohortequation is implemented as a multivariable Cox proportional hazardregression.

In some embodiments, the pooled cohort equation assessment filter isfired at least when the assessment survey results indicate the subjecthas a 10-year risk for atherosclerotic cardiovascular disease (e.g., a10-year risk of experiencing an atherosclerotic cardiovascular disease(ASCVD) event) that is less than 10%, as determined by the pooled cohortequation. In some embodiments, the pooled cohort equation assessmentfilter is also configured to be fired when one or more value provided bythe subject does not enable the pooled cohort equation to calculate anASCVD event risk for the subject (e.g., a subject age of less than fortywould provide an incalculable risk using the equations provided in Goffet al.). In some embodiments, the pooled cohort equation assessmentfilter behaves as a filter of the second category class when a valueprovided by the subject does not enable the pooled cohort equation tocalculate an ASCVD event risk. E.g., when the pooled cohort equationfilter is fired for receiving a value that is out of a range of valuesrequired to calculate an ASCVD event risk, the device issues a warningto the subject (e.g., requiring the subject discuss taking a angiotensinII receptor blocker pharmaceutical composition with a medicalprofessional) that must be acknowledged prior to being authorized toreceive a provision of the angiotensin II receptor blockerpharmaceutical composition, rather than automatically terminating theprocess, as would be done when a filter of the first category class isfiltered. In some embodiments, the pooled cohort equation assessmentfilter is fired when the assessment survey results indicate the subjectis younger than forty years old.

The pooled cohort equation estimates the probability of incurring a hardatherosclerotic cardiovascular disease (ASCVD) event in a given periodof time, such as in the next 5 years, the next 10 years, or in thelifetime of a subject. In some embodiments, the pooled cohort equationfor the pooled cohort equation filter is calculated using the guidelinesset forth in Goff, D C Jr, et al., J. Am. Coll. Cardiol., 63:2935-59(2014), the content of which is hereby incorporated by reference.Following the Goff et al. (Id.) calculation of the 10-year risk estimatefor a hard ASCVD event using the pooled cohort equations is done as aseries of steps. The natural log of the age of the subject, totalcholesterol, HDL-C, and systolic blood pressure are first calculatedwith the systolic blood pressure being either a treated or untreatedvalue. For example, calculation of the pooled cohort equations estimatethe probability of a Caucasian male subject 55 years of age with totalcholesterol 213 mg/dL, HDL-C 50 mg/dL, untreated systolic blood pressure120 mm Hg, nonsmoker, and without diabetes determine the probability ofa hard ASCVD event in the next 10 years using Goff Id. begins by firsttaking the natural log of the subject's age (4.01), the natural log ofthe subject's total cholesterol (5.36), the natural log of the subject'sHDL-C (3.91), and the natural log of the subject's systolic bloodpressure (4.79). These values are then multiplied by the coefficientsfrom the equation (“Coefficient” column of Table A of Goff Id.) for thespecific race-gender group of the individual to obtain“coefficient×values.” That is:

-   -   multiply the natural log of the subject's age (4.01) by the        coefficient 12.344 to obtain the “coefficient×value” of 49.47,    -   multiply the natural log of the subject's total cholesterol        (5.36) by the coefficient 11.853 to obtain the        “coefficient×value” of 63.55,    -   multiply the natural log of the subject's HDL-C (3.91) by the        coefficient −7.990 to obtain the “coefficient×value” of −31.26,        and    -   multiply the natural log of the subject's systolic blood        pressure (4.79) by the coefficient 1.764 to obtain the        “coefficient×value” of 8.45.    -   Any appropriate interaction terms are also calculated. Following        Goff Id., in the case of the Caucasian male subject 55 years of        age, the interaction terms are:    -   the Log Age (4.01)×Log total Cholesterol (5.36) multiplied by        the coefficient −2.664 to obtain the “coefficient×value” of        −57.24 and    -   Log Age (4.01)×Log HDL-C (3.91) multiplied by the coefficient        1.769 to obtain the “coefficient×value” of 27.73.        The sum of these “coefficient×values” is then calculated for the        individual (49.47+63.55−31.26+8.45−57.24+27.73=60.69). The        estimated 10-year risk of a first hard ASCVD event is formally        calculated as 1 minus the baseline survival rate at 10 years for        the gender/race (in this example Caucasian male), raised to the        power of the exponent of the “Coefficient×Value” sum calculated        above minus the race (Caucasian) and gender (Male) specific        overall mean “Coefficient×Value” sum; or, in equation form:

1−0.9144^(e(60.69-61.18))

where the number 0.9144 is the baseline survival rate at 10 years forCaucasian males from Goff Id, the number 60.69 is the“coefficient×value” calculated for the particular subject as detailedabove, and the number 61.18 is the race (Caucasian) and gender (Male)specific overall mean “Coefficient×Value” from Goff Id. This equates toa 5.3% probability of a first hard ASCVD event within 10 years.

In some embodiments, using the Goff et al. calculation, the risk for thefatal cardiovascular disease used in calculating the pooled cohortequation is a 10-year risk, and a first threshold value, e.g., athreshold value which when the risk of the subject is determined to beless than fires the filter, is about 10% risk. In some embodiments, therisk for the fatal cardiovascular disease used in calculating the pooledcohort equation is a 10-year risk, and the first threshold value is a10% risk.

In some embodiments, the pooled cohort equation filter incorporates someor all of the characteristics listed in Table 3, e.g., as determinedfrom a set of survey results, to derive a subject risk foratherosclerotic cardiovascular disease. For example, in someembodiments, the plurality of assessment survey results includes 2, 3,4, 5, 6, 7, 8, 9, 10, or all 11 of the characteristics listed in Table3. The pooled cohort equation filter is fired when the subject's riskfor atherosclerotic cardiovascular disease exceeds a threshold level ofrisk.

TABLE 3 Example Characteristics Used for Pooled Cohort Equation FilterResult Exemplary Characteristics 1 a gender of the subject 2 an age ofthe subject 3 a total cholesterol level of the subject 4 a HDLcholesterol count of the subject 5 a systolic blood pressure of thesubject 6 a race of the subject 7 whether the subject is taking one ormore medications for hypertension 8 a smoking status of the subject 9 adiabetes status of the subject 10 whether the subject has a familyhistory of heart or stroke before the age of 60 11 a hsCRP level of thesubject

In some embodiments, the pooled cohort equation used to calculate a riskof fatal cardiovascular disease for the pooled cohort equation filter iscalculated using the guidelines set forth in Perk J. et al., EuropeanGuidelines on cardiovascular disease prevention in clinical practice,European Heart Journal 33:1635-1701 (2012), which is hereby incorporatedby reference herein. In some embodiments, the pooled cohort equationassessment filter follows a low CVD risk SCORE chart, which incorporatesthe gender of the subject, the age of the subject, the total cholesterollevel of the subject, the systolic blood pressure of the subject, and asmoking status of the subject, as set forth in Perk J. et al., Supra. Insome embodiments, a conversion factor is used to convert a risk of fatalcardiovascular disease to a risk of fatal plus nonfatal hardcardiovascular disease events, as set forth in Catapano A L et al., 2016ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J.2016 Oct. 14; 37(39):2999-3058, which is hereby incorporated byreference herein. In one embodiment, the pooled cohort equation filterincorporates at least survey results 1-9 as provided in Table 3, e.g.,according to the method described in Goff, D C Jr, et al., J. Am. Coll.Cardiol., 63:2935-59 (2014). In another embodiment, the assessmentsurvey results include at least survey results 1-10 as provided in Table3. In another embodiment, the assessment survey results include at leastsurvey results 1-9 and 11 as provided in Table 3. In another embodiment,the assessment survey results include at least survey results 1-11 asprovided in Table 3.

In some embodiments, using the SCORE guidelines, the risk for the fatalcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and a first threshold value, e.g., a threshold valuewhich when the risk of the subject is determined to be less than firesthe filter, is a 5% risk. In some embodiments, the risk for the fatalcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and the first threshold value is a 10% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof a cardiovascular disease-related death for the pooled cohort equationfilter is calculated using the guidelines set forth in Teramoto et al.,Japan Atherosclerosis Society. Executive summary of the JapanAtherosclerosis Society (JAS) guidelines for the diagnosis andprevention of atherosclerotic cardiovascular diseases in Japan-2012version, J Atheroscler Thromb., 2013; 20(6):517-23, which is herebyincorporated by reference herein. In some embodiments, the pooled cohortequation assessment filter follows the NIPPON DATA80 absolute riskassessment charts, which incorporate the gender of the subject, the ageof the subject, the total cholesterol level of the subject, the systolicblood pressure of the subject, and a smoking status of the subject, asset forth in Teramoto et al., Supra. In some embodiments, the pooledcohort equation also incorporates a glucose level of the subject.

In some embodiments, using the NIPPON DATA80 guidance, the risk for thecoronary artery death used in calculating the pooled cohort equation isa 10-year risk, and a first threshold value, e.g., a threshold valuewhich when the risk of the subject is determined to be less than firesthe filter, is a 0.5% risk. In some embodiments, the risk for the fatalcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and the first threshold value is a 1% risk. In someembodiments, the risk for the fatal cardiovascular disease used incalculating the pooled cohort equation is a 10-year risk, and the firstthreshold value is a 2% risk. In other embodiments, the risk for thefatal cardiovascular disease used in calculating the pooled cohortequation is a 10-year risk, and the first threshold value is a 3%, 4%,or 5% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof atherosclerotic cardiovascular disease for the pooled cohort equationassessment filter is calculated using the guidelines set forth in YangX. et al., Predicting the 10-Year Risks of AtheroscleroticCardiovascular Disease in Chinese Population: The China-PAR Project(Prediction for ASCVD Risk in China). Circulation. 2016 Nov. 8;134(19):1430-1440, which is hereby incorporated by reference herein. Insome embodiments, the pooled cohort equation assessment filter followsthe China-PAR gender specific equations, which incorporate the gender ofthe subject (e.g., to determine which equation to use), the age of thesubject, the systolic blood pressure of the subject, a blood pressuretreatment status of the subject, the total cholesterol level of thesubject, a smoking status of the subject, a diabetes mellitus status ofthe subject, the waist circumference of the subject, a geographicresidential-region of the subject (e.g., for Chinese residents only,either northern China or southern China), an urbanizationresidential-region of the subject (e.g., for men residing in China only,either urban or rural), and family history of atheroscleroticcardiovascular disease (e.g., for men only), as set forth in Yang X. etal., Supra and at Supplemental Information. In some embodiments, thepooled cohort equation also incorporates an HDL cholesterol level of thesubject and/or a cholesterol treatment status of the subject.

In some embodiments, using the China-PAR guidance, the risk for theatherosclerotic cardiovascular disease used in calculating the pooledcohort equation is a 10-year risk, and a first threshold value, e.g., athreshold value which when the risk of the subject is determined to beless than fires the filter, is a 5% risk. In some embodiments, the riskfor the atherosclerotic cardiovascular disease used in calculating thepooled cohort equation is a 10-year risk, and the first threshold valueis a 7.5% risk. In some embodiments, the risk for the atheroscleroticcardiovascular disease used in calculating the pooled cohort equation isa 10-year risk, and the first threshold value is a 7.5% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof atherosclerotic cardiovascular disease for the pooled cohort equationassessment filter 216-5 is calculated using the guidelines set forth inNational Vascular Disease Prevention Alliance, Guidelines for themanagement of absolute cardiovascular disease risk, 2012, which ishereby incorporated by reference herein. In some embodiments, the pooledcohort equation assessment filter follows the Australian cardiovascularrisk charts, which incorporate the gender of the subject, the age of thesubject, the systolic blood pressure of the subject, the ratio of totalcholesterol to HDL levels of the subject, and a smoking status of thesubject, as set forth in Absolute cardiovascular disease riskmanagement: Quick reference guide for health professionals, 2012,National Stroke Foundation. In some embodiments, the pooled cohortequation also incorporates the decent of the subject (e.g., in Australiaonly, for Aboriginal, Tones Strait Islander, or other populations).

In some embodiments, using the Australian cardiovascular risk charts,the risk for the atherosclerotic cardiovascular disease used incalculating the pooled cohort equation is a 5-year risk, and a firstthreshold value, e.g., a threshold value which when the risk of thesubject is determined to be less than fires the filter, is a 5% risk. Insome embodiments, the risk for the atherosclerotic cardiovasculardisease used in calculating the pooled cohort equation is a 5-year risk,and the first threshold value is a 10% risk. In some embodiments, therisk for the atherosclerotic cardiovascular disease used in calculatingthe pooled cohort equation is a 5-year risk, and the first thresholdvalue is a 16% risk. In some embodiments, the risk for theatherosclerotic cardiovascular disease used in calculating the pooledcohort equation is a 5-year risk, and the first threshold value is a 20%risk. In some embodiments, the risk for the atheroscleroticcardiovascular disease used in calculating the pooled cohort equation isa 5-year risk, and the first threshold value is a 25% risk.

In some embodiments, the pooled cohort equation used to calculate a riskof atherosclerotic cardiovascular disease for the pooled cohort equationassessment filter 216-5 is calculated using the guidelines set forth inAnderson T J et al., 2016 Canadian Cardiovascular Society Guidelines forthe Management of Dyslipidemia for the Prevention of CardiovascularDisease in the Adult, Can J Cardiol. 2016 November; 32(11):1263-1282,which is hereby incorporated by reference herein. In some embodiments,the pooled cohort equation assessment filter follows a Framingham HeartStudy Risk Score equation (FRS), which incorporates the gender of thesubject, the age of the subject, the systolic blood pressure of thesubject, a blood pressure treatment status of the subject, the totalcholesterol level of the subject, and an HDL cholesterol level of thesubject, a smoking status of the subject, a diabetes mellitus status ofthe subject, and a CVD event incident status of the subject, as setforth in D'Agostino R B Sr et al., General cardiovascular risk profilefor use in primary care: the Framingham Heart Study. Circulation. 2008Feb. 12; 117(6):743-53, which is hereby incorporated by referenceherein. In some embodiments, the pooled cohort equation assessmentfilter follows a modified Framingham Heart Study Risk Score equation(FRS), which incorporates the gender of the subject, the age of thesubject, the systolic blood pressure of the subject, a blood pressuretreatment status of the subject, the total cholesterol level of thesubject, and an HDL cholesterol level of the subject, a smoking statusof the subject, a diabetes mellitus status of the subject, and a CVDevent incident status of the subject, and a family history status ofpremature cardiovascular disease, as set forth in Anderson T J et al.,Supra. In some embodiments, the pooled cohort equation assessment filterfollows a Cardiovascular Life Expectancy Model (CLEM), as set forth inGrover S A et al., Estimating the benefits of modifying risk factors ofcardiovascular disease: a comparison of primary vs secondary prevention.Arch Intern Med. 1998 Mar. 23; 158(6):655-62, which is herebyincorporated by reference herein.

In some embodiments, using the Canadian Cardiovascular Society guidance,the risk for the atherosclerotic cardiovascular disease used incalculating the pooled cohort equation is a 10-year risk, and a firstthreshold value, e.g., a threshold value which when the risk of thesubject is determined to be less than fires the filter, is a 5% risk. Insome embodiments, the risk for the atherosclerotic cardiovasculardisease used in calculating the pooled cohort equation is a 10-yearrisk, and the first threshold value is a 10% risk. In some embodiments,the risk for the atherosclerotic cardiovascular disease used incalculating the pooled cohort equation is a 10-year risk, and the firstthreshold value is a 15% risk.

In some embodiments, a probability of the occurrence of a hard ASCVDevent in a given period of time (e.g., within the next 10 years), e.g.,as calculated above, is modified by considering one or both of thefamilial history of the subject for premature heart attacks or strokesand the hsCRP level of the subject. This inclusion is to reduce alikelihood of over-predicting adverse events, e.g., in subjects withouta familial history of adverse events and/or with healthy hsCRP levels.

In some embodiments, e.g., when the assessment survey results indicatethat the subject has a sufficient risk prior to determining a risk usinga pooled cohort equation, e.g., where the subject is at least eightyyears old or the subject has had an atherosclerotic cardiovascularevent, the device bypasses the pooled cohort equation assessment filter(e.g., even if the plurality of assessment survey results would indicatethat the subject has an ASCVD risk falling below a minimum thresholdrisk, or that the subject is of an age that renders calculation of anASCVD risk impossible, the pooled cohort equation assessment filter isnot fired). For example, as illustrated in FIG. 8, in response todetermining that the subject has an ASCVD history (e.g., has experiencedan ASCVD event or had a heart procedure) at 820 or determining that thesubject is at least 80 years of age at 830, the device, optionally,generates a record of an exempting condition and then, prior to applyingone or more survey results to the pooled cohort equation at 865, thedevice determines whether an exempting condition is present. Forinstance, in some embodiments if an assessment survey result indicatesthat the respective subject has an ASCVD history the pooled cohortequation assessment filter is bypassed (e.g., the assessment proceedsdirectly from 820 of FIG. 8A to 870 of FIG. 8C). In some embodiments,the exemption record is a record of one or more assessment surveyresults, e.g., the device pre-checks earlier recorded assessment surveyresults associated with ASCVD history and/or age prior to proceedingwith pooled cohort equation filter 865. In some embodiments, theexemption record is a record separate from the survey result thatindicates the exempting condition, and the device checks for separaterecords indicating the presence of an exempting condition beforeproceeding with pooled cohort equation filter 865.

Referring to block 460 of FIG. 4D, in some embodiments the plurality ofassessment survey results further includes whether the subject isallergic to the angiotensin II receptor blocker pharmaceuticalcomposition, and the first plurality of assessment filters includes anadverse reaction assessment filter. Accordingly, the adverse reactionassessment filter is fired when the assessment survey results indicatethat the subject is allergic to the angiotensin II receptor blockerpharmaceutical composition. In some embodiments, the adverse reactionassessment filter is fired when the assessment survey results indicatethat the subject has developed an adverse reaction to an angiotensin IIreceptor blocker pharmaceutical composition in the past. In someembodiments, the adverse reaction assessment filter is fired when theassessment survey results indicate that the subject has developed anadverse reaction to any angiotensin II receptor blocker pharmaceuticalcomposition in the past.

Referring to block 462 of FIG. 4D, in some embodiments the plurality ofassessment survey results further includes whether the subject has had aliver problem, and the first plurality of assessment filters includes aliver problem assessment filter. Accordingly, the liver problemassessment filter is fired when the assessment survey results indicatethat the subject has liver disease. In some embodiments, an advancedliver disease that is capable of firing the liver problem assessmentfilter includes symptoms and/or conditions such as inflammation of theliver, fibrosis, cirrhosis, end-stage liver disease (ESLD), cancer ofthe liver, and/or liver failure. In some embodiments, a liver problemassessment filter is included in the first plurality of filters when theangiotensin II receptor blocker pharmaceutical composition includescandesartan as an active ingredient. In some embodiments, a liverproblem assessment filter is included in the first plurality of filterswhen the angiotensin II receptor blocker pharmaceutical compositionincludes telmisartan as an active ingredient. In some embodiments, aliver problem assessment filter is included in the first plurality offilters when the angiotensin II receptor blocker pharmaceuticalcomposition includes losartan as an active ingredient. In someembodiments when the liver problem assessment filter is fired, thesubject is provided a recommendation to discuss taking a lower dosage ofthe angiotensin II receptor blocker pharmaceutical composition with amedical practitioner.

In some embodiments, rather than being implemented as a first type offilter, a liver problem assessment filter triggers a reduction in thedosage of the angiotensin II receptor blocker pharmaceutical compositionthat the subject can be qualified. In some embodiments, such a dosagereduction filter is included when the angiotensin II receptor blockerpharmaceutical composition includes telmisartan, losartan, orcandesartan as an active ingredient.

Referring to block 464 of FIG. 4E, in some embodiments the method alsoincludes running all or a portion of the assessment survey resultsagainst a second plurality of assessment filters of a second categoryclass 220. When a respective assessment filter in the second pluralityof assessment filters is fired, the subject is provided with a warning226 corresponding to the respective filter (e.g., filter warning 228-4corresponds to filter 222-4). In some embodiments, the warning 226 isprovided as a next step, e.g., prior to applying assessment surveyresults to any subsequent filters, after the corresponding filter isfired. For example, with respect to FIG. 8C, in some embodiments, e.g.,when the kidney problem assessment filter is triggered at 870, thedevice would provide the subject with a warning prior to proceeding tothe electrolyte blood level assessment filter at 875, e.g., requiringthe subject confirm they have discussed their history of kidney diseasewith a health care provider and the healthcare provider still recommendstaking an angiotensin II receptor blocker pharmaceutical composition. Insome embodiments, the warning 226 is provided after applying assessmentsurvey results to all subsequent filters. For example, as illustrated inFIG. 8C, in some embodiments, e.g., when the kidney problem assessmentfilter is triggered at 870, the device would proceed to the electrolyteblood level assessment filter at 875 prior to transmitting a warning tothe subject, and then transmit all warnings corresponding to filters ofthe second category class, at 885, after survey results have beenapplied to all subsequent filters.

In some embodiments, the second plurality of assessment filters 222 ofthe second category class 220 includes the assessment filters listed inTable 4.

TABLE 4 Example Assessment Filters of the Second Category Class FilterExample Criteria 1b a kidney problem assessment filter 2b an electrolyteblood level assessment filter 3b potassium supplement assessment filter4b colesevelam interaction assessment filter

It is contemplated that, in some embodiments, any one or more of thefilters provided in Table 4 will not be included in the second pluralityof assessment filters. For example, in some embodiments, acharacteristic associated with a particular survey result will beinformative when qualifying a subject for one particular angiotensin IIreceptor blocker pharmaceutical composition but not for anotherangiotensin II receptor blocker pharmaceutical composition. Accordingly,it is contemplated that the second plurality of assessment filtersincludes any sub-set of filters provided in Table 4. Likewise, theskilled artisan may know of other assessment filters, not provided inTable 4, that may be combined with any subset of the filters provided inTable 4 to form the second plurality of assessment filters results usedin the methods described herein. In one embodiment, the second pluralityof assessment filters includes at least filters 1b and 2b. In oneembodiment, the second plurality of assessment filters includes at leastfilters 1b-3b. In one embodiment, the second plurality of assessmentfilters includes at least filters 1b, 2b, and 4b. In one embodiment, thesecond plurality of assessment filters includes at least filters 1b-4b.

Referring to block 466 of FIG. 4E, in some embodiments, the secondplurality of assessment filters includes a kidney problem assessmentfilter (e.g., kidney problem assessment filter 222-2 in FIG. 3 and/orfilter 1a in Table 4). The kidney problem assessment filter isconfigured to be fired at least when the plurality of assessment surveyresults indicate that the subject has had a kidney problem. In someembodiments, the kidney problem assessment filter is configured to befired at least when the plurality of assessment survey results indicatethat the subject has been diagnosed with kidney disease. Symptoms ofkidney problems include fatigue, a feeling of coldness, shortness ofbreath, a feeling of faintness, dizziness, weakness, a feeling ofitchiness, or swelling of the hands and feet. When the kidney problemassessment filter is fired, the device transmits a warning correspondingto the kidney problem assessment filter, and requires the user toacknowledge the warning before authorizing a provision of theangiotensin II receptor blocker pharmaceutical composition. In someembodiments, e.g., where the angiotensin II receptor blocker includeseprosartan or olmesartan as an active ingredient, the kidney problemassessment filter is implemented as a first category class assessmentfilter (e.g., the subject is deemed not qualified for the angiotensin IIreceptor blocker when the filter is fired), rather than a secondcategory class assessment filter.

Referring to block 468 of FIG. 4E, in some embodiments the secondplurality of assessment filters includes an electrolyte blood levelassessment filter (e.g., electrolyte blood level assessment filter 222-2in FIG. 3 and/or filter 2a in Table 4). The electrolyte blood levelassessment filter is configured to be fired at least when the pluralityof assessment survey results indicate that the subject has had anabnormal electrolyte blood level. In some embodiments, the kidneyproblem assessment filter is configured to be fired at least when theplurality of assessment survey results indicate that the subject hasbeen diagnosed with an abnormal electrolyte blood level. In someembodiments, an abnormal electrolyte blood level is a value that isoutside of a range of 4.5-5.5 mEq/L of calcium, a range of 97-107 mEq/Lof chloride, a range of 3.5-5.3 mEq/L potassium, a range of 1.5-2.5mEq/L magnesium, and/or a range of 136-145 mEq/L sodium. Symptoms ofabnormal electrolyte blood levels include irregular heartbeat,confusion, blood pressure changes, nervous system and/or bone disorders,weakness and/or twitching of the muscles, numbness, fatigue, irregularheartbeat, and/or blood pressure changes. When the electrolyte bloodlevel assessment filter is fired, the device transmits a warningcorresponding to the electrolyte blood level assessment filter, andrequires the user to acknowledge the warning before authorizing aprovision of the angiotensin II receptor blocker pharmaceuticalcomposition.

Referring to block 470 of FIG. 4E, in some embodiments the plurality ofassessment survey results further includes whether the subject hastaking a potassium supplement or a salt substitute that includespotassium, and the second plurality of assessment filters includes apotassium supplement assessment filter. For instance, in someembodiments, a potassium supplement assessment filter is included whenthe angiotensin II receptor blocker pharmaceutical composition includesirbesartan or losartan as an active ingredient. Accordingly, thepotassium supplement assessment filter is configured to be fired atleast when the plurality of assessment survey results indicates that thesubject is taking a potassium supplement or a salt substitute thatincludes potassium. When the potassium supplement assessment filter isfired, the device transmits a warning corresponding to the potassiumsupplement assessment filter, and requires the user to acknowledge thewarning before authorizing a provision of the angiotensin II receptorblocker pharmaceutical composition

Referring to block 474 of FIG. 4E, in some embodiments the plurality ofassessment survey results further includes whether the subject is takingcolesevelam, and the second plurality of assessment filters includes acolesevelam interaction assessment filter. When the colesevelaminteraction assessment filter is fired, the device transmits a warningcorresponding to the colesevelam interaction assessment filter, andrequires the user to acknowledge the warning before authorizing aprovision of the angiotensin II receptor blocker pharmaceuticalcomposition. In some embodiments, a colesevelam interaction assessmentfilter is included in the second plurality of filters when theangiotensin II receptor blocker pharmaceutical composition includesolmesartan as an active ingredient.

In some embodiments, as described above, the second plurality ofassessment filters includes a liver problem assessment filter (e.g., theliver problem assessment filter is a second category class filter). Forinstance, in some embodiments the angiotensin II receptor blockerpharmaceutical composition includes candesartan, losartan, ortelmisartan and the liver problem assessment filter is included in thesecond plurality of assessment filters. Accordingly, when the liverproblem assessment filter is fired, the device transmits a warningcorresponding to the liver problem assessment filter, and requires theuser to acknowledge the warning before authorizing a provision of theangiotensin II receptor blocker pharmaceutical composition. In someembodiments, the warning is a recommendation, and/or prompt to discusswith a medical practitioner, to take a reduced dosage of the angiotensinII receptor blocker (e.g., half a recommended dosage).

Referring to block 476 of FIG. 4E, in some embodiments the warning 226corresponding to a respective filter 222 in the second plurality ofassessment filters includes a prompt for the subject to indicate whetherthey have discussed the risk factor underlying the respective filter inthe second plurality of assessment filters that was fired with a healthcare practitioner (e.g., a licensed medical practitioner), e.g., and thehealth care practitioner indicated that the subject should take anangiotensin II receptor blocker pharmaceutical composition in view ofthe underlying risk factor. Accordingly, acknowledgement is obtainedfrom the subject when the subject indicates that they have discussed therisk factor underlying the respective filter in the second plurality ofassessment filters that was fired with a health care provider. Forexample, message 702 in FIG. 7 illustrates a warning that is generic toany fired filters. In some embodiments, the warning is specific to aparticular filter (e.g., filter warning 226 in FIG. 2), e.g.,communicating to the user why the respective filter was fired.

In some embodiments, an acknowledgment from the user is verified by thehealth care practitioner (e.g., the method requires verification inorder for authorization of the provision of the angiotensin II receptorblocker pharmaceutical composition), e.g., in order to verify anaccuracy of the assessment survey results of the subject. In someembodiments, e.g., when the acknowledgment is verified by the heath carepractitioner, the subject is deemed a trusted subject, such thatverification of future results is not required.

Referring to block 478 of FIG. 4E, the method includes obtainingacknowledgment from the subject for any warning 226 issued to thesubject by any filter 222 in the second plurality of assessment filters.If a filter 216 in the first plurality of assessment filters fires, thesubject is denied access to the over-the-counter angiotensin II receptorblocker pharmaceutical composition.

Blocks 480 through 488.

Referring to block 480 of FIG. 4F, the process control proceeds to thefulfillment process when no filter 216 in the first plurality ofassessment filters has been fired and the subject has acknowledged eachwarning 226 associated with each filter 222 in the second plurality ofassessment filters that was fired. In some embodiments, the fulfillmentprocess includes storing an indication in a user profile 234 of aninitial order date and/or destination for the angiotensin II receptorblocker pharmaceutical composition. The initial order date is utilized,for example, to verify at least a refill status of a provision of theangiotensin II receptor blocker. The initial order date is alsoutilized, for example, to verify at least an elapsed period of timebetween an initial order and a future re-order. Such verification isrequired in order to ensure that certain tests (e.g., blood pressuretests) are taken regularly.

The fulfillment process further includes communicating anover-the-counter drug facts label 230 for the angiotensin II receptorblocker pharmaceutical composition to the subject. In some embodiments,the drug facts label 230 is communicated to the subject in real-time,e.g., within the same user interface as used for the qualificationassessment process. In some embodiments, the over-the-counter drug factslabel 230 specifies what the angiotensin II receptor blockerpharmaceutical composition is for (e.g., to lower blood pressure, totreat heart disease, etc.) and any risks associated with taking theangiotensin II receptor blocker pharmaceutical composition (e.g.,drug-drug interactions, pharmacokinetic interactions, adverse reactions,etc.). For instance, in some embodiments, upon confirmation from thesubject that the over the counter drug facts label 230 has been receivedand read, the subject is authorized for provision of a dosage of from 4mg to 600 mg of angiotensin II receptor blocker no more than once perday. In some embodiments, the subject is authorized for a provision of adosage of from 40 mg to 80 mg of angiotensin II receptor blocker (e.g.,azilsartan) no more than once per day (block 484). In some embodiments,the subject is authorized for a provision of a dosage of from 8 mg to 16mg of angiotensin II receptor blocker (e.g., candesartan) no more thanonce per day. In some embodiments, the subject is authorized for aprovision of a dosage of from 80 mg to 160 mg of angiotensin II receptorblocker (e.g., valsartan) no more than once per day. In someembodiments, the subject is authorized for a provision of a dosage offrom 20 mg to 40 mg of angiotensin II receptor blocker (e.g.,olmesartan, telmisartan, etc.) no more than once per day. In someembodiments, the subject is authorized for a provision of a dosage offrom 400 mg to 600 mg of angiotensin II receptor blocker (e.g.,eprosartan) no more than once per day. In some embodiments, the subjectis authorized for a provision of a dosage of from 25 mg to 50 mg ofangiotensin II receptor blocker (e.g., losartan) no more than once perday. In some embodiments, the subject is authorized for a provision of adosage of from 150 mg to 300 mg of angiotensin II receptor blocker(e.g., irbesartan) no more than once per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 20 mg to 100 mg ofazilsartan no more than once per day. In some embodiments, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of from 40 mg to 80 mg of azilsartan no more than once per day.In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 40 mg of azilsartan no more thanonce per day. In some embodiments, upon confirmation from the subjectthat the over the counter drug facts label has been received and read,the subject is authorized for provision of a dosage of 80 mg ofazilsartan no more than once per day. In some embodiments, theangiotensin II receptor blocker pharmaceutical composition includesazilsartan medoxomil.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 4 mg to 32 mg ofcandesartan no more than once per day. In some embodiments, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of from 8 mg to 16 mg of candesartan no more than once per day.In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 8 mg of candesartan no more thanonce per day. In some embodiments, upon confirmation from the subjectthat the over the counter drug facts label has been received and read,the subject is authorized for provision of a dosage of 16 mg ofcandesartan no more than once per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 40 mg to 320 mg ofvalsartan no more than once per day. In some embodiments, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of from 80 mg to 160 mg of valsartan no more than once per day.In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 80 mg of valsartan no more thanonce per day. In some embodiments, upon confirmation from the subjectthat the over the counter drug facts label has been received and read,the subject is authorized for provision of a dosage of 160 mg ofvalsartan no more than once per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 20 mg to 80 mg oftelmisartan no more than once per day. In some embodiments, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of from 20 mg to 40 mg of telmisartan no more than once per day.In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 20 mg of telmisartan no morethan once per day. In some embodiments, upon confirmation from thesubject that the over the counter drug facts label has been received andread, the subject is authorized for provision of a dosage of 40 mg oftelmisartan no more than once per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 400 mg to 600 mg ofeprosartan no more than once per day. In some embodiments, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of 400 mg of eprosartan no more than once per day. In someembodiments, upon confirmation from the subject that the over thecounter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 600 mg of eprosartan no morethan once per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 5 mg to 40 mg of olmesartanno more than once per day. In some embodiments, upon confirmation fromthe subject that the over the counter drug facts label has been receivedand read, the subject is authorized for provision of a dosage of from 20mg to 40 mg of olmesartan no more than once per day. In someembodiments, upon confirmation from the subject that the over thecounter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 20 mg of olmesartan no more thanonce per day. In some embodiments, upon confirmation from the subjectthat the over the counter drug facts label has been received and read,the subject is authorized for provision of a dosage of 40 mg ofolmesartan no more than once per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 25 mg to 100 mg of losartanno more than once per day. In some embodiments, upon confirmation fromthe subject that the over the counter drug facts label has been receivedand read, the subject is authorized for provision of a dosage of from 25mg to 50 mg of losartan no more than once per day. In some embodiments,upon confirmation from the subject that the over the counter drug factslabel has been received and read, the subject is authorized forprovision of a dosage of 25 mg of losartan no more than once per day. Insome embodiments, upon confirmation from the subject that the over thecounter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 50 mg of losartan no more thanonce per day.

Furthermore, in some embodiments upon confirmation from the subject thatthe over the counter drug facts label has been received and read, thesubject is authorized for provision of a dosage of from 75 mg to 300 mgof irbesartan no more than once per day. In some embodiments, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, the subject is authorized for provision of adosage of from 150 mg to 300 mg of irbesartan no more than once per day.In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of 150 mg of irbesartan no morethan once per day. In some embodiments, upon confirmation from thesubject that the over the counter drug facts label has been received andread, the subject is authorized for provision of a dosage of 300 mg ofirbesartan no more than once per day.

Referring to block 482 of FIG. 4F, in some embodiments the fulfillmentprocess further includes authorizing provision of the angiotensin IIreceptor blocker pharmaceutical composition to the subject. Theauthorization occurs upon confirmation from the subject that theover-the-counter drug facts label 230 has been received and read by thesubject. In some embodiments, this authorization includes a destinationassociated with the subject. In some embodiments, the destinationassociated with the subject is stored in the user profile 234 (block486). In some embodiments, the destination associated with the subjectis a physical address including a street address, a Post Office box, apharmacy associated with the subject, a health care provider associatedwith the subject, and/or one or more coordinates (e.g., longitude,latitude, elevation). In some embodiments, the provision of theangiotensin II receptor blocker pharmaceutical composition to thesubject includes shipping the angiotensin II receptor blockerpharmaceutical composition to the physical address associated with thesubject (block 488). In some embodiments, the provision of theangiotensin II receptor blocker pharmaceutical composition to thesubject includes shipping the angiotensin II receptor blockerpharmaceutical composition to a pharmacy associated and/or a locationassociated with a health care provider of the subject and/or an officeof a medical practitioner associated with the subject.

Blocks 500 Through 506.

Referring to block 502 of FIG. 5A, a goal of the present disclosure isto qualify subjects (e.g., a re-fulfillment process) forover-the-counter delivery of an angiotensin II receptor blockerpharmaceutical composition to lower blood pressure, e.g., thereby,treating and/or preventing heart disease, using a computer system suchas an angiotensin II receptor blocker pharmaceutical composition OTCdispensing device 250. As illustrated in FIG. 2, the angiotensin IIreceptor blocker pharmaceutical composition OTC dispensing device (e.g.,device 250) includes one or more processors (e.g., processor 274) and amemory (e.g., memory 192 and/or 290). The memory stores non-transitoryinstructions that, when executed by the one or more processors, performa method. In some embodiments, the present disclosure provides a methodfor qualifying a subject for a reorder (e.g., a reassessment) of anangiotensin II receptor blocker pharmaceutical composition. In someembodiments, the qualification for a reorder of the angiotensin IIreceptor blocker pharmaceutical composition follows an initialqualification (e.g., an assessment) of the subject, as described herein.In some embodiments, the qualification for a refill of the angiotensinII receptor blocker pharmaceutical composition follows issuance of aprescription to the subject for the angiotensin II receptor blockerpharmaceutical composition. For example, in some embodiments, a subjectwho is new to the qualification process is asked whether they previouslyreceived a prescription for the angiotensin II receptor blockerpharmaceutical composition. Accordingly, if the subject indicates thatthey have not previously received a prescription, the subject isdirected to an initial qualification method and, if the subjectindicates that they have previously received a prescription, the subjectis directed to the refill qualification method, e.g., as describedbelow.

In some embodiments a re-fulfillment procedure is performed. There-fulfillment procedure is responsive to receiving a re-order requestfrom the subject for the angiotensin II receptor blocker pharmaceuticalcomposition. In some embodiments, a prompt to initiate there-fulfillment procedure is sent to user device 102 associated with thesubject after a predetermined amount of time associated with a durationof dosages previously delivered to the subject (e.g., the user isreminded to fulfill their order of the angiotensin II receptor blockerpharmaceutical composition just before, or just after, the user isscheduled to run out of a previously delivered provision.

In some embodiments the angiotensin II receptor blocker pharmaceuticalcomposition includes one of candesartan, eprosartan, irbesartan,losartan, olmesartan, telmisartan, or valsartan. These angiotensin IIreceptor blocker compositions are described in Farnham et al., 2000,“Angiotensin II receptor antagonists,” The Lancet, 335(9204), pg. 594,the content of which is hereby incorporated by reference. in someembodiments, the lowering of blood pressure is to treat and/or preventheart disease.

Referring to blocks 508 and 510 of FIG. 5A, in some embodiments there-fulfillment procedure includes conducting a reassessment survey ofthe subject. The reassessment survey is configured to obtain a pluralityof reassessment survey results. These results are derived fromcorresponding reassessment survey questions (e.g., the device 250transmits one or more reassessment survey questions to the user,prompting a response, and then receives a response to the one or morereassessment survey questions back from the subject). In someembodiments, the plurality of reassessment survey results includes someor all of the characteristics listed in Table 5. For example, in someembodiments, the plurality of reassessment survey results includes 1, 2,3, 4, 5, 6, or all 7 of the characteristic listed in Table 5. In oneembodiment, the reassessment survey questions and results include atleast characteristics 1-6 as provided in Table 5. In one embodiment, thereassessment survey questions and results include at leastcharacteristics 2-6 as provided in Table 5.

In some embodiments, the reassessment survey results includes at leastone of: a systolic blood pressure and/or a diastolic blood pressure ofthe subject (e.g., responsive to a reassessment survey question that isassociated with and/or applied to (905, 910) a blood pressurereassessment survey filter of a first category class 214-6), whether thesubject is one of pregnant, breastfeeding, or planning to becomepregnant (e.g., responsive to a reassessment survey question that isassociated with and/or applied to (915) a pregnancy reassessment filterof a first category class 214-7), whether the subject has started takinga medication that interacts with the angiotensin II receptor blockerpharmaceutical composition since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition (e.g.,responsive to a survey question that is associated with and/or appliedto (920, 925, 930) a drug interaction reassessment filter of a firstcategory class 216-8), whether the subject has experienced symptoms ofhypotension since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition (e.g., responsive to areassessment survey question that is associated with and/or applied to(940) a hypotension reassessment filter of a first category class916-9), whether the subject has developed an abnormal electrolyte bloodlevel since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition (e.g., responsive to areassessment survey question that is associated with and/or applied to(945) an electrolyte blood level reassessment filter 216-10 of a firstcategory class), and whether the subject has developed a kidney problemsince receiving their last provision of the angiotensin II receptorblocker pharmaceutical composition (e.g., responsive to a surveyquestion that is associated with and/or applied to (850) a kidneyproblem reassessment filter of a first category class 216-11).

In some embodiments, the reassessment survey includes questions thatelicit responses providing some or all of the characteristics listed inTable 5. In some embodiments, the reassessment survey includes questionscorresponding to each of the survey results required for the methodsdescribed herein. In other embodiments, the reassessment survey includesquestions corresponding to only a subset of the reassessment surveyresults required for the methods described herein. In such embodiments,other reassessment survey results required for the methods describedherein are acquired through other means (e.g., uponregistration/subscription for a service associated with qualifying thesubject for over-the-counter medication, from a healthcare provider,from a prior survey, from a database associated with a pharmacy, etc.)For example, in some embodiments, the subject provides a personalmedical identification associated with an insurer, a hospital, or otherhealthcare provider and information about the subject required for themethods described herein, e.g., one or more survey results, is acquiredfrom a preexisting database associated with the personal medicalidentification (e.g., a last cholesterol or blood pressure measurementdetermined for the subject).

TABLE 5 Example Medical Information Elicited from Reassessment SurveyQuestions Result Exemplary Characteristics 1 a blood pressure of thesubject, 2 whether the subject is one of (i) pregnant, (ii)breastfeeding, or (iii) planning to become pregnant 3 whether thesubject has started taking a medication that interacts with theangiotensin II receptor blocker pharmaceutical composition sincereceiving their last provision of the angiotensin II receptor blockerpharmaceutical composition 4 whether the subject has experiencedsymptoms of hypotension since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition 5 whether thesubject has developed an abnormal electrolyte blood level sincereceiving their last provision of the angiotensin II receptor blockerpharmaceutical composition 6 whether the subject has developed a kidneyproblem since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition 7 whether the subject hasdeveloped a side effect associated with the angiotensin II receptorblocker since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition

It is contemplated that, in some embodiments, any one or more of thesurvey questions provided in Table 5 will not be included in thereassessment survey (e.g., will not be used for the reassessment). Forexample, in some embodiments, a characteristic associated with aparticular survey questions will be informative when qualifying asubject for one particular angiotensin II receptor blocker but not foranother angiotensin II receptor blocker. For instance, a reassessmentsurvey question is queried for azilsartan qualifying reassessmentsurveys but not for olmesartan qualifying reassessment surveys. Theskilled artisan will recognize that different angiotensin II receptorblockers carry different risk and drug interaction profiles.Accordingly, survey information required for qualifying a subject foraccess to one angiotensin II receptor blocker with a known adverse druginteraction may not be necessary for qualifying the same subject foraccess to a second angiotensin II receptor blocker.

Accordingly, it is contemplated that the reassessment survey questionselicit responses to any sub-set of survey results provided in Table 5.For brevity, all possible combinations of the characteristics providedin Table 5 are not specifically delineated here. However, the skilledartisan will easily be able to envision any particular subset of surveyquestions designed to elicit responses to any subset of characteristicsprovided in Table 5. Likewise, the skilled artisan may know of othersurvey questions, not provided in Table 5, that may be combined with anysubset of the survey questions provided in Table 5 to form thereassessment survey questions used in the methods described herein.

Referring to block 512 of FIG. 5A, all or a portion the reassessmentresults are run against a first plurality of reassessment filters of thefirst category class 214-2. When a respective reassessment filter in thefirst plurality of reassessment filters is fired (e.g., when areassessment survey result indicates that a triggering condition 218 hasbeen met), the subject is deemed not qualified for the angiotensin IIreceptor blocker pharmaceutical composition and the method is terminatedwithout delivery of the angiotensin II receptor blocker pharmaceuticalcomposition.

Referring to blocks 514 through 532 of FIGS. 5A and 5B, specific filtersin the first plurality of reassessment filters and their exemplarytriggering conditions that cause the corresponding filter to fire aredetailed.

In some embodiments, the first plurality of reassessment filters of thefirst category class includes some or all of the filters listed in Table6. For example, in some embodiments, the first plurality of reassessmentfilters includes 1, 2, 3, 4, 5, or all 6 of the filters listed in Table6.

TABLE 6 Exemplary Third Plurality of Filters of the First Category ClassFilter Exemplary Criteria 1c a blood pressure reassessment filter 2c apregnancy reassessment filter 3c a drug interaction reassessment filter4c a hypotension reassessment filter 5c an electrolyte blood levelreassessment filter 6c a kidney problem reassessment filter

It is contemplated that, in some embodiments, any one or more of thefilters provided in Table 6 will not be included in the first pluralityof reassessment filters. For example, in some embodiments, acharacteristic associated with a particular reassessment survey resultwill be informative when qualifying a subject for one particularangiotensin II receptor blocker but not for another angiotensin IIreceptor blocker. Likewise, the skilled artisan may know of otherfilters, not provided in Table 6, which may be combined with any subsetof the assessment filters provided in Table 2 to form the firstplurality of reassessment filters results used in the methods describedherein. For brevity, all possible combinations of the reassessmentfilters provided in Table 6 are not specifically delineated here. In oneembodiment, the first plurality of reassessment filters includes all offilters 1c-6c as provided in Table 6. In one embodiment, the firstplurality of reassessment filters includes filters 2c-6c as provided inTable 6.

It is contemplated that, in some embodiments, any one or more of thefilters provided in Table 6 will not be included in the first pluralityof reassessment filters. For example, in some embodiments, acharacteristic associated with a particular reassessment survey resultwill be informative when qualifying a subject for one particularangiotensin II receptor blocker but not for another angiotensin IIreceptor blocker. Likewise, the skilled artisan may know of otherfilters, not provided in Table 6, which may be combined with any subsetof the assessment filters provided in Table 2 to form the firstplurality of reassessment filters results used in the methods describedherein. For brevity, all possible combinations of the reassessmentfilters provided in Table 6 are not specifically delineated here.

Referring to block 514 of FIG. 5A, in some embodiments the firstplurality of reassessment filters includes a blood pressure reassessmentfilter 216-6. In some embodiments, the blood pressure reassessmentfilter is as described above in relation to the blood pressureassessment filter 216-2. In some embodiments, the blood pressurereassessment filter is configured to be fired at least when theplurality of reassessment survey results indicates that the subject hashypertension. In some embodiments, the reassessment survey resultsindicate that the subject has hypertension (e.g., an indication of stage1 hypertension) if the subject has a systolic blood pressure of greaterthan or equal to 130 mm Hg and/or a diastolic blood pressure of greaterthan or equal to 80 mm Hg.

Referring to block 516 and 518 of FIG. 5A, in some embodiments the firstplurality of reassessment filters includes a pregnancy reassessmentfilter 2016-7. In some embodiments, the pregnancy reassessment filter isas described above in relation to the pregnancy assessment filter 216-1.In some embodiments, the pregnancy reassessment filter is configured tobe fired at least when the plurality of reassessment survey resultsindicates that the subject is pregnant or the subject is breastfeeding.In some embodiments, the pregnancy reassessment filter is alsoconfigured to be fired when the subject is planning on becomingpregnant. When the pregnancy reassessment filter is fired, the subjectis not permitted to obtain the angiotensin II receptor blockerpharmaceutical composition over-the-counter (e.g., the method isterminated without authorizing re-provision of the angiotensin IIreceptor blocker pharmaceutical composition to the subject).

Referring to block 520 through 526 of FIG. 5B, in some embodiments, thefirst plurality of reassessment filters includes a drug interactionreassessment filter 2016-8. In some embodiments, the drug interactionreassessment filter is as described above in relation to the druginteraction assessment filter 226-3. In some embodiments, the druginteraction reassessment filter is configured to be fired at least whenthe plurality of reassessment survey results indicates that the subjectis taking (e.g., has started taking) a medication that interacts withthe angiotensin II receptor blocker pharmaceutical composition. Aspreviously described, these interactions can be pharmacodynamicdrug-drug interactions or pharmacokinetic drug-drug interactions.Typically, the interactions (e.g., triggering conditions 224) that arecapable of firing the drug interaction reassessment filter are the sameas the interactions that are capable of firing the drug interactionassessment filter assuming that the angiotensin II receptor blockerpharmaceutical composition is the same between the fulfillment processand the re-fulfillment process. For instance, in some embodiments thedrug interaction reassessment filter is fired when the plurality ofreassessment survey results indicates that the subject is taking alithium medication. In some embodiments, the drug interactionreassessment filter is fired when the plurality of reassessment surveyresults indicates that the subject is taking a non-steroidalanti-inflammatory medication. In some embodiments, the drug interactionreassessment filter is fired when the plurality of reassessment surveyresults indicates that the subject is taking a blood pressure medication(e.g., a medication for high blood pressure).

Referring to block 528 of FIG. 5B, in some embodiments, the firstplurality of reassessment filters of the first category class 214-2includes a hypotension reassessment filter. In some embodiments, thehypotension reassessment filter is configured to be fired at least whenthe reassessment survey results indicate that the subject hasexperienced hypotension (e.g., a systolic blood pressure of less than orequal to 90 mm Hg or a diastolic blood pressure of less than or equal to60 mm Hg) since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition. In some embodiments, e.g.,when the plurality of reassessment survey results indicate that thesubject has experienced symptoms of hypotension, the device fires thehypotension reassessment filter and transmits, to the subject, advice tovisit a doctor. In some embodiments, rather than being implemented as afirst class of filter, the hypotension reassessment filter isimplemented as a second class of filter, e.g., where firing of thefilter requires the subject confirm they have discussed the risks ofhypotension with a physician prior to being qualified for a re-order ofthe angiotensin II receptor blocker pharmaceutical composition.

Referring to block 530 of FIG. 5B, in some embodiments the firstplurality of reassessment filters of the first category class includesan electrolyte blood level reassessment filter. In some embodiments, theelectrolyte blood level reassessment filter is as described above withrespect to the electrolyte blood level assessment filter. In someembodiments, the electrolyte blood level reassessment filter isconfigured to be fired at least when the plurality of reassessmentsurvey results indicates that the subject has developed an abnormalelectrolyte blood level since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition. In someembodiments, rather than being implemented as a first class of filter,the electrolyte blood level reassessment filter is implemented as asecond class of filter, e.g., where firing of the filter requires thesubject confirm they have discussed the risks of abnormal electrolyteblood levels with a physician prior to being qualified for a re-order ofthe angiotensin II receptor blocker pharmaceutical composition.

Referring to block 532 of FIG. 5B, in some embodiments the firstplurality of reassessment filters of the first category class includes akidney problem reassessment filter. In some embodiments, the kidneyproblem reassessment filter is as described above with respect to thekidney problem assessment filter. In some embodiments, the kidneyproblem reassessment filter is configured to be fired at least when theplurality of reassessment survey results indicates that the subject hasdeveloped a kidney problem since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition. In someembodiments, rather than being implemented as a first class of filter,the kidney problem reassessment filter is implemented as a second classof filter, e.g., where firing of the filter requires the subject confirmthey have discussed the risks of kidney problems with a physician priorto being qualified for a re-order of the angiotensin II receptor blockerpharmaceutical composition.

Referring to block 534 of FIG. 5C, in some embodiments the method alsoincludes running all or a portion of the reassessment survey resultsagainst a second plurality of reassessment filters of the secondcategory class 220-2. When a respective filter in the second pluralityof reassessment filters is fired, the subject is provided with a warningcorresponding to the respective filter. In some embodiments, the warningis provided as a next step, e.g., prior to applying reassessment surveyresults to any subsequent filters, after the corresponding filter isfired. For example, with respect to FIGS. 9A and 9B, in someembodiments, the device would provide the subject with a warning priorto proceeding to the proceeding filter, e.g., requiring the subjectconfirm they have discussed warning with a health care provider and thehealthcare provider still recommends taking an angiotensin II receptorblocker pharmaceutical composition. In some embodiments, the warning isprovided after applying reassessment survey results to all subsequentfilters.

Referring to block 498, in some embodiments the second plurality ofreassessment filters includes one or more of an impaired renal functionreassessment filter, an abnormal potassium serum level reassessmentfilter, and a side effect reassessment filter.

In some embodiments, the second plurality of reassessment filters of thesecond category class 220-2 includes some or all of the filters listedin Table 7. For example, in some embodiments, the second plurality ofreassessment filters includes 1, 2, or all 3 of the filters listed inTable 7.

TABLE 7 Example Reassessment Filters of the Second Category Class FilterExemplary Criteria 1a a renal function reassessment filter 2a apotassium serum level reassessment filter 3a a side effects reassessmentfilter

It is contemplated that, in some embodiments, any one or more of thefilters provided in Table 7 will not be included in the second pluralityof reassessment filters. For example, in some embodiments, acharacteristic associated with a particular survey result will beinformative when qualifying a subject for one particular angiotensin IIreceptor blocker pharmaceutical composition but not for anotherangiotensin II receptor blocker pharmaceutical composition. Accordingly,it is contemplated that the second plurality of reassessment filtersincludes any sub-set of filters provided in Table 7. Likewise, theskilled artisan may know of other filters, not provided in Table 7, thatmay be combined with any subset of the filters 222 provided in Table 7to form the fourth plurality of filters results used in the methodsdescribed herein. In some embodiments, no reassessment filters of thesecond category class are included in the re-order method. In one theembodiments, one or more of filters 1d-3d, as provided in Table 7, areincluded in a second plurality of reassessment filters, applied toinformation obtained by the reassessment survey.

Referring to block 536 of FIG. 5C, in some embodiments the reassessmentsurvey results further includes whether the subject has experienced animpaired renal function since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition. Accordingly,in some embodiments the second plurality of reassessment filtersincludes a renal function reassessment filter that is fired at leastwhen the plurality of reassessment results indicates that the subjecthas experienced, since receiving their last provision of the angiotensinII receptor blocker pharmaceutical composition, an impaired renalfunction.

Referring to block 538 of FIG. 5C, in some embodiments the reassessmentsurvey results further includes whether the subject has experienced anabnormal potassium serum level since receiving their last provision ofthe angiotensin II receptor blocker pharmaceutical composition.Accordingly, in some embodiments the second plurality of reassessmentfilters includes a potassium serum level reassessment filter that isfired at least when the plurality of reassessment results indicates thatthe subject has experienced, since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition, an abnormalpotassium serum level.

Referring to block 540 of FIG. 5C, in some embodiments the reassessmentsurvey results further includes whether the subject has developed a sideeffect associated with the angiotensin II receptor blockerpharmaceutical composition since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition. Accordingly,in some embodiments, the second plurality of reassessment filtersfurther includes a side effect reassessment filter that is configured tobe fired at least when the reassessment survey results indicate that thesubject has developed a side effect since receiving their last provisionof the angiotensin II receptor blocker pharmaceutical composition. Sideeffects that are capable of triggering (e.g., triggering condition) theside effect filter include hypotension. In some embodiments, sideeffects that are capable of triggering (e.g., triggering condition) theside effect filter include high potassium serum levels, swelling of theface, swelling of the tongue, swelling of the throat, a skin rash, sinuspain and/or sinus congestion (e.g., sinusitis), back pain, and/ordiarrhea. In some embodiments, side effects that are capable oftriggering (e.g., triggering condition) the side effect filter includeproblems of the kidney such as swelling of the feet, swelling of theankles, swelling of the hands, unexplained weight gain, and/or heartfailure. In some embodiments, side effects that are capable oftriggering (e.g., triggering condition) the side effect filter includechest pain, orthostatic hypotension, anemia, hyperkalemia, hypoglycemia,and/or a urinary tract infection.

Referring to block 542 of FIG. 5C, in some embodiments the method alsoincludes obtaining acknowledgment from the subject for each warningissued to the subject by any filter in the second plurality ofreassessment filters. As described with respect to the warnings issuedin conjunction with the second plurality of assessment filters of thesecond category class, in some embodiments, the warning includes aprompt for the subject to indicate whether they have discussed the riskfactor underlying the respective filter in the second plurality ofreassessment filters that was fired with a health care practitioner(e.g., a licensed medical practitioner), e.g., and the health carepractitioner indicated that the subject should take a angiotensin IIreceptor blocker pharmaceutical composition in view of the underlyingrisk factor. Accordingly, acknowledgement is obtained from the subjectwhen the subject indicates that they have discussed the risk factorunderlying the respective filter in the second plurality of reassessmentfilters that was fired with a health care provider.

Referring to block 544 of FIG. 5D, in some embodiments the procedurefurther includes proceeding with the re-fulfillment process when there-fulfillment process is not already terminated by the firing of afilter in the first plurality of reassessment filters (e.g., thepregnancy reassessment filter). Moreover, in order for there-fulfillment process to complete the subject is required toacknowledge each warning associated with each filter 222-2 in the secondplurality of reassessment filters that was fired.

Referring to block 546 of FIG. 5D, in some embodiments when a respectivefilter in the first plurality of reassessment filters or secondplurality of reassessment filters is fired, a record associated with thefiring of the respective filter is stored (e.g., memorializing anadverse event that is required to be reported to a regulatory agency).This record is stored in an adverse event module 242 which includesrecords of filter firing events associated with a plurality of subjects(e.g., an aggregation of adverse events associated with the angiotensinII receptor blocker pharmaceutical composition across a population ofsubjects taking the angiotensin II receptor blocker pharmaceuticalcomposition over-the-counter). In some embodiments, an indication of theadverse event is communicated to a third party (e.g., a medicalpractitioner associated with the subject, a health care provider of thesubject, and/or a manufacturer/promoter of the angiotensin II receptorblocker pharmaceutical composition). In some embodiments, the indicationis automatically stored in the adverse event module 242 when submittedby a subject as part of the reassessment survey.

In some embodiments, an adverse event that is required to be reportedincludes an allergic reaction (e.g., a side effect and/or a druginteraction) of any type or kind as described above. In someembodiments, an adverse event that is required to be reported includesan anticipated and/or recent change in pregnancy status of a respectivesubject. In some embodiments, an adverse event that is required to bereported includes an indication that a respective subject hasexperienced symptoms of hypotension (e.g., since receiving their lastprovision of the angiotensin II receptor blocker). In some embodiments,an adverse event that is required to be reported includes a worsening ofkidney function for a respective subject. Furthermore, in someembodiments an adverse event that is required to be reported includes anindication of a respective subject experiencing a significant (e.g.,detectable) electrolyte imbalance (e.g., an abnormal electrolyte bloodlevel).

Referring to block 548 of FIG. 5D, in some embodiments there-fulfillment process also includes storing an indication in the userprofile 234 of the subject of a re-order 238 for the angiotensin IIreceptor blocker pharmaceutical composition. The re-fulfillment processfurther includes communicating an over-the-counter drug facts label 230for the angiotensin II receptor pharmaceutical composition to thesubject. As previously described, the communication of theover-the-counter drug facts label 230 can occur in a variety of means.Upon confirmation from the subject that the over-the-counter drug factslabel 230 has been received and read, the method includes authorizing are-order provision of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject. In some embodiments, this re-order provisionincludes the destination of the subject.

FIG. 8 illustrates an example method (800) (e.g., performed at anelectric device) for qualifying a subject for an over-the-counterangiotensin II receptor blocker pharmaceutical composition. In someembodiments, the method of FIG. 8 is utilized when the subject has notbeen previously qualified for the medication (e.g., an assessment forthe medication). In some embodiments, the method of FIG. 8 is utilizedwhen the subject was previously qualified for the angiotensin IIreceptor blocker pharmaceutical composition but a predetermined periodof time elapsed since the previous qualification occurred (e.g., themost recent qualification of the subject was greater than one year ago).

Referring to FIG. 8, the device prompts (802) the subject to acknowledgea privacy notice. Since the present disclosure requires the subject toknow and input sensitive medical information (e.g., information only thesubject and a medical practitioner have access to), privacy of thisinformation is important. Once the subject has acknowledged they havethe requisite privacy for continuing, the device prompts (804) the userto confirm that they know their blood pressure and cholesterol levels(e.g., because in some embodiments the subject must know their bloodpressure and their total cholesterol, including their HDL, values inorder to complete the qualification process). If the subject indicatesthey do not know their blood pressure and/or cholesterol level, theprocess terminates 895-2 without authorizing provision of theangiotensin II receptor blocker pharmaceutical composition, andoptionally transmits advice to the user to return later, e.g., once theyknow their blood pressure and cholesterol levels. If the subjectindicates they know their blood pressure and cholesterol levels, theprocess continues.

The device prompts the subject to provide information about theirpregnancy status and then applies (805) the answer received from thesubject to a pregnancy assessment filter. When the pregnancy assessmentfilter is fired (e.g., when the answer indicates the subject ispregnant, breastfeeding, or planning to become pregnant), the deviceterminates (895-1) the qualification process without authorizingprovision of the angiotensin II receptor blocker pharmaceutical agentand, optionally, transmits advice to the user as to why they should nottake the angiotensin II receptor blocker pharmaceutical agent.

When the pregnancy reassessment filter is not fired, the device proceedswith the qualification process, prompting the subject to indicatewhether they are taking a medication that interacts with the angiotensinII receptor blocker and then applies (810) the answer received from thesubject to a drug interaction assessment filter. When the druginteraction assessment filter is fired (e.g., when the answer indicatesthe subject is taking a medication that interacts with the angiotensinII receptor blocker), the device terminates (895-1) the qualificationprocess without authorizing provision of the angiotensin II receptorblocker pharmaceutical agent and, optionally, transmits advice to theuser as to why they should not take the angiotensin II receptor blockerpharmaceutical agent.

When the drug interaction assessment filter is not fired, the deviceproceeds with the qualification process, prompting the subject toprovide their blood pressure and then applies (815) the answer receivedfrom the subject to a blood pressure assessment filter. When the bloodpressure assessment filter is fired (e.g., when the answer indicates thesubject has hypertension), the device terminates (895-3 through 895-6)the qualification process without authorizing provision of theangiotensin II receptor blocker pharmaceutical agent. Optionally, whenthe device terminates the process in response to determining (815-2) thesubject has slightly elevated blood pressure, the device transmits(895-3) advice for the subject to maintain a healthy diet and toexercise. Optionally, when the device terminates the process in responseto determining (815-3) the subject has normal blood pressure, the devicetransmits (895-4) advice for the subject that they do not need anangiotensin II receptor blocker pharmaceutical agent. Optionally, whenthe device terminates the process in response to determining (815-4) thesubject has hypertension stage 2, the device transmits (895-5) advicefor the subject to discuss obtaining a prescription for an angiotensinII receptor blocker pharmaceutical agent with a medical professional.Optionally, when the device terminates the process in response todetermining (815-4) the subject is in hypertensive crisis, the devicetransmits (895-6) advice for the subject to seek emergency medical care.

When the blood pressure assessment filter is not fired, the deviceproceeds with the qualification process, prompting the subject toprovide information about their cardiovascular history (820), promptingthe subject to provide their gender (825), prompting the subject toprovide their age (830), prompting the subject to provide their race(835), whether they are currently taking blood pressure medication(840), whether they have diabetes (845), their history of smoking (850),and their cholesterol levels (855). If no record of an exemptioncondition was created (e.g., the subject has not had a cardiovascularproblem or heart procedure and is younger than 80), the devicecalculates an atherosclerotic cardiovascular disease (ASCVD) event riskfor the subject (e.g., based on the answers to prompts (815-855) andapplies (865) the calculated risk to a pooled cohort equation filter.When the pooled cohort equation filter is fired (e.g., when the risk ofan ASCVD event is less than 10 percent or is incalculable), the deviceterminates (895-3, 895-7) the qualification process without authorizingprovision of the angiotensin II receptor blocker pharmaceutical agent.Optionally, when the device terminates the process in response todetermining (865-2) the subject has an incalculable risk for an ASCVDevent, the device transmits (895-7) advice for the subject to visit amedical professional to discuss whether taking an angiotensin IIreceptor blocker pharmaceutical agent is appropriate. Optionally, whenthe device terminates the process in response to determining (865-3)that the subject has a low risk of an ASCVD event (e.g., less than 10%),the device transmits (895-3) advice for the subject to maintain ahealthy diet and to exercise.

When the pooled cohort equation assessment filter is not fired, thedevice proceeds with the qualification process, prompting the subject toindicate whether they have had kidney problems and then applies (870)the answer received from the subject to a kidney problem assessmentfilter. In some embodiments, when the kidney problem assessment filteris fired (e.g., when the answer indicates the subject has had a kidneyproblem), the device initiates (880-1) an override procedure (e.g.,creates a record indicating that the user must confirm they havediscussed taking an angiotensin II receptor blocker pharmaceuticalcomposition with a health care provider).

When the kidney problem assessment filter is not fired, the deviceproceeds with the qualification process, prompting the subject toindicate whether they have been told they have abnormal electrolyteblood levels and applies (875) the answer received from the subject toan electrolyte blood level assessment filter. In some embodiments, whenthe electrolyte blood level assessment filter is fired (e.g., when theanswer indicates the subject has a had an abnormal electrolyte bloodlevel), the device initiates (880-2) an override procedure (e.g.,creates a record indicating that the user must confirm they havediscussed taking an angiotensin II receptor blocker pharmaceuticalcomposition with a health care provider).

In some embodiments, the device proceeds with the qualification process,determining (882) whether the override procedure has been triggered(e.g., by firing of either of the kidney problem or electrolyte bloodlevel assessment filters). If the override procedure has been triggered,the device prompts (884) the user to confirm that they have spoken witha medical professional about taking an angiotensin II receptor blockerpharmaceutical composition (e.g., in view of the underlying risk factorthat triggered the kidney problem and/or electrolyte blood levelassessment filters) and the medical professional recommended taking theangiotensin II receptor blocker pharmaceutical composition. If theuser's response indicates they have not spoken with a medicalprofessional or the medical professional did not recommend taking theangiotensin II receptor blocker pharmaceutical composition, the deviceterminates (895-8) the process and, optionally, transmits advice for thesubject to consult a medical professional.

If the override procedure was not triggered, or the override procedurewas triggered and the subject's response indicated that a medicalprofessional recommended they take an angiotensin II receptor blockerpharmaceutical composition (e.g., in view of the underlying risk factortriggering the override procedure), the device proceeds with thequalification process, prompting (885) the subject to confirm theiranswers. If the user confirms their answers, the device transmits (890)a drug facts label for angiotensin II receptor blocker pharmaceuticalcomposition and prompts the user to read the drug facts label. If thesubject confirms they have read the drug facts label, the deviceproceeds to authorize (895) purchase of the angiotensin II receptorblocker pharmaceutical composition.

FIG. 9 illustrates an example method for qualifying a subject for arefill (e.g., a reassessment) of an over-the-counter angiotensin IIreceptor blocker pharmaceutical composition (e.g., following aprescription from a medical professional or initial qualification by amethod described herein). Referring to FIG. 9, the device prompts (902)the subject to acknowledge a privacy notice. Once the subject hasacknowledged they have the requisite privacy for continuing, the devicedetermines (905) whether a blood pressure input for the subject isrequired. When a new blood pressure input is required (e.g., when thesubject's profile does not include a record of the subject's bloodpressure taken within the past month, e.g., for a first reorder process,or within the past six months, e.g., for a subsequent reorder process),the device prompts (910) the subject to confirm they know their bloodpressure. When the user indicates they do not know their blood pressure,the device terminates (995-1) the process without authorizing provisionof the angiotensin II receptor blocker pharmaceutical agent, optionallytransmitting advice for the user to return once they know their bloodpressure. When the user indicates they do know their blood pressure, thedevice proceeds with the process, prompting the user to indicate whethertheir blood pressure is below a threshold target level (e.g., under130/80, evidencing the efficacy of the angiotensin II receptor blockerpharmaceutical agent) and applies (910) the answer received from thesubject to a blood pressure reassessment filter. When the blood pressurereassessment filter is fired (e.g., when the reassessment answerindicates the subject has a blood pressure is not below a thresholdtarget level, e.g., 130/80), the device terminates (995-2) thequalification process, optionally transmitting advice for the subject todiscuss taking a prescription-strength angiotensin II receptor blockerpharmaceutical agent with a medical professional.

When the blood pressure reassessment filter is not fired, or thesubject's answer indicates their blood pressure is below the thresholdtarget level, the device proceeds with the qualification process,prompting the subject to provide information about their pregnancystatus and then applies (915) the answer received from the subject to apregnancy reassessment filter. In some embodiments, when the pregnancyreassessment filter is fired (e.g., when the answer indicates thesubject is pregnant, breastfeeding, or planning to become pregnant), thedevice creates (990-1) a record of an adverse event (e.g., aggregated inan adverse event data store having records of adverse events from aplurality of users), terminates (995-3) the qualification process and,optionally, transmits advice to the user as to why they should not takethe angiotensin II receptor blocker pharmaceutical composition.

When the pregnancy reassessment filter is not fired, the device proceedswith the qualification process, prompting the subject to provideinformation about their current medications and then applies (820, 825,830) the answer received from the subject to a drug interactionreassessment filter. In some embodiments, the device prompts the subjectto provide information about whether the subject is currently taking alithium medication (920). In some embodiments, the device prompts thesubject to provide information about whether the subject is currentlytaking a non-steroidal anti-inflammatory medication (925). In someembodiments, the device prompts the subject to provide information aboutwhether the subject is currently taking a blood pressure medication(e.g., a high blood pressure medication) (930). When the druginteraction reassessment filter is fired (e.g., when the answerindicates the subject has started taking a medication that interactionswith the angiotensin II receptor blocker pharmaceutical composition),the device terminates (995-3) the qualification process and, optionally,transmits advice to the user as to why they should not take theangiotensin II receptor blocker pharmaceutical composition.

When the drug interaction reassessment filter is not fired, the deviceproceeds with the qualification process, prompting the subject toindicate whether they have developed hypotension since receiving theirlast provision of the angiotensin II receptor blocker and then applies(940) the answer received from the subject to a hypotension reassessmentfilter. When the hypotension reassessment filter is fired (e.g., whenthe answer indicates the subject has developed symptoms of hypotensionsince receiving their last provision of the angiotensin II receptorblocker), the device optionally creates a record of an adverse event(e.g., aggregated in an adverse event data store having records ofadverse events from a plurality of users) and initiates (935-2) anoverride procedure (e.g., creates a record indicating that the user mustconfirm they have discussed taking angiotensin II receptor blockerpharmaceutical composition with a health care professional).

When the hypotension reassessment filter is not fired, the deviceproceeds with the qualification process, promoting the subject toindicate whether they have developed abnormal electrolyte blood levelssince receiving their last provision of the angiotensin II receptorblocker and then applies (945) the answer received from the subject toan electrolyte blood level reassessment filter. When the electrolyteblood level reassessment filter is fired (e.g., when the answerindicates the subject has developed an abnormal electrolyte blood levelsince receiving their last provision of the angiotensin II receptorblocker), the device optionally creates a record of an adverse event(e.g., aggregated in an adverse event data store having records ofadverse events from a plurality of users) and initiates (935-2) anoverride procedure (e.g., creates a record indicating that the user mustconfirm they have discussed taking angiotensin II receptor blockerpharmaceutical composition with a health care professional).

When the electrolyte blood level reassessment filter is not fired, thedevice proceeds with the qualification process, prompting the subject toindicate whether they have developed a kidney problem and then applies(950) the answer received from the subject to a kidney problemreassessment filter. When the kidney problem reassessment filter isfired (e.g., when the answer indicates the subject has developed akidney problem since receiving their last provision of the angiotensinII receptor blocker pharmaceutical composition), the device creates(990-2) a record of an adverse event (e.g., aggregated in an adverseevent data store having records of adverse events from a plurality ofusers) and initiates (935-3) an override procedure (e.g., creates arecord indicating that the user must confirm they have discussed takingan angiotensin II receptor blocker pharmaceutical composition with ahealth care professional).

The device proceeds with the qualification process, determining (935)whether the override procedure has been triggered (e.g., by firing ofany one of hypotension or kidney problem reassessment filters, etc.). Ifthe override procedure has been triggered, the device prompts (937) theuser to confirm that they have spoken with a medical professional abouttaking an angiotensin II receptor blocker pharmaceutical composition(e.g., in view of the underlying risk factor that triggered thehypotension or kidney problem reassessment filter) and the medicalprofessional recommended taking the angiotensin II receptor blockerpharmaceutical composition. If the user's response indicates they havenot spoken with a medical professional or the medical professional didnot recommend taking the angiotensin II receptor blocker pharmaceuticalcomposition, the device terminates (995-3) the process and, optionally,transmits advice for the subject to consult a medical professional.

If the override procedure was not triggered, or the override procedurewas triggered and the subject's response indicated that a medicalprofessional recommended they take an angiotensin II receptor blockerpharmaceutical composition (e.g., in view of the underlying risk factortriggering the override procedure), the device proceeds with there-qualification process, prompting (955) the subject to confirm theiranswers. If the user confirms their answers, the device transmits (960)a drug facts label for the angiotensin II receptor blockerpharmaceutical composition and prompts the user to read the drug factslabel. If the subject confirms they have read the drug facts label, thedevice proceeds to authorize purchase of the angiotensin II receptorblocker pharmaceutical composition

Specific Embodiments

In one aspect, the disclosure provides methods, software, and computersystems for qualifying a human subject for over-the-counter delivery ofan angiotensin II receptor blocker pharmaceutical composition to lowerblood pressure, e.g., treating or preventing heart disease. In oneembodiment, a computer system (e.g., computer system 250 in FIG. 2)includes instructions for conducting an assessment survey of the subject(e.g., assessment module 252 in FIG. 2) to obtain information about thesubject necessary to run against at least two series of filters (e.g.,first assessment filter category class 214 in FIG. 2 and secondassessment filter category class 220 in FIG. 2). The computer systemalso includes instructions for running the assessment survey resultsagainst the assessment filters. Filters 216 in the first series ofassessment filters prevent authorization for delivery of the OTCangiotensin II receptor blocker where the subject's assessment surveyresults identify a contraindication for the OTC angiotensin II receptorblocker. Filters 222 in the second series of assessment filters generatea warning 226 where the subject's survey results identify a risk factorfor the OTC angiotensin II receptor. In some embodiments, the warning226 includes a prompt requiring the subject to confirm they havediscussed the risk factor with a physician in order to proceed withqualification for the OTC a blocker.

In one aspect, the disclosure provides methods, software, and computersystems for qualifying a human subject for a re-order (e.g.,reassessment) for over-the-counter delivery of an angiotensin IIreceptor blocker pharmaceutical composition to lower blood pressure,e.g., treating or preventing heart disease. In one embodiment, acomputer system includes instructions, responsive to receiving are-order request from the subject for the angiotensin II receptorblocker pharmaceutical composition, performing a re-fulfillmentprocedure (e.g., reassessment procedure) including, for conducting areassessment survey of the subject to obtain reassessment survey resultsfor qualifying the subject for the re-order, e.g., associated with atleast two series of filters (e.g., a first series of reassessmentfilters of a first category class 214-2 in FIG. 2 and second series ofreassessment filters of a second category class 220-2 in FIG. 2). Thecomputer system also includes instructions for running the reassessmentsurvey results against the reassessment filters. Filters 216 in thefirst series of reassessment filters prevent authorization for deliveryof the OTC angiotensin II receptor blocker where the subject's surveyresults identify a contraindication for the OTC angiotensin II receptorblocker. Filters 222 in the second series of reassessment filtersgenerate a warning 226 where the subject's reassessment survey resultsidentify a risk factor for the OTC angiotensin II receptor blocker. Insome embodiments, the warning 226 includes a prompt requiring thesubject to confirm they have discussed the risk factor with a physicianin order to proceed with qualification for the OTC angiotensin IIreceptor blocker.

The computer system includes instructions for proceeding with are-fulfillment process only when no filters in the first series ofreassessment filters was fired and the subject acknowledged each warningassociated with each filter in the second plurality of reassessmentfilters that was fired. The computer system also includes instructionsfor storing an indication in a subject profile of a re-order for theangiotensin II receptor blocker pharmaceutical composition The computersystem also includes instructions for communicating an over-the-counterdrug facts label 230 for the angiotensin II receptor blockerpharmaceutical composition to the subject and, upon confirmation thatthe over-the-counter drug facts label has been received and read,authorizing provision of the OTC angiotensin II receptor blockerpharmaceutical composition to the subject.

In one aspect, the disclosure provides a computer system for qualifyinga human subject for over-the-counter delivery of an angiotensin IIreceptor blocker pharmaceutical composition to lower blood pressure. Thecomputer system comprising one or more processors and a memory, thememory comprising non-transitory instructions which, when executed bythe one or more processor, perform a method for qualifying a humansubject for over-the-counter delivery of the angiotensin II receptorblocker pharmaceutical composition. The method includes conducting anassessment survey of the subject thereby obtaining a plurality ofassessment survey results necessary to run against a first plurality ofassessment filters of a first category class and a second plurality ofassessment filters of a second category class. The method then includesrunning all or a portion of the first plurality of assessment surveyresults against a first plurality of assessment filters of a firstcategory class, wherein, when a respective filter in the first pluralityof assessment filters is fired, the subject is deemed not qualified fordelivery of the angiotensin II receptor blocker pharmaceuticalcomposition and the method is terminated without delivery of theangiotensin II receptor blocker pharmaceutical composition to thesubject. The method then includes running all or a portion of theplurality of assessment survey results against a second plurality ofassessment filters of a second category class, wherein, when arespective filter in the second plurality of assessment filters isfired, the subject is provided with a warning corresponding to therespective filter. The method also includes obtaining acknowledgmentfrom the subject for the warning issued to the subject by any filter inthe second plurality of assessment filters. The method also includesproceeding with a fulfillment process when no filter in the firstplurality of assessment filters has been fired and the subject hasacknowledged each warning associated with each filter in the secondplurality of assessment filters that was fired. The fulfillment processincludes: storing an indication in a subject profile of an initial orderfor the angiotensin II receptor blocker pharmaceutical composition,communicating an over-the-counter drug facts label for the angiotensinII receptor blocker pharmaceutical composition to the subject, andauthorizing, upon confirmation from the subject that theover-the-counter drug facts label has been received and read, provisionof the angiotensin II receptor blocker pharmaceutical composition to thesubject. In some embodiments, the authorization includes a destinationassociated with the subject.

In some embodiments, the plurality of assessment survey results includesa plurality of assessment survey results selected from the surveyresults listed in Table 1. In one embodiment, the plurality ofassessment survey results includes: whether the subject is one of (i)pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,whether the subject is taking a medication that interacts with theangiotensin II receptor blocker pharmaceutical composition, a systolicblood pressure of the subject, a diastolic blood pressure of thesubject, an age of the subject, information required to calculate a riskof atherosclerotic cardiovascular disease for the subject, whether thesubject has ever had an abnormal electrolyte blood level, and whetherthe subject has ever had a kidney problem.

In some embodiments, the first plurality of assessment filters includesa plurality of assessment filters selected from the filters listed inTable 2. In one embodiment, the first plurality of assessment filtersincludes blood pressure assessment, a pregnancy assessment filter, adrug interaction assessment filter, an age assessment filter, and apooled cohort equation assessment filter.

In some embodiments, the second plurality of assessment filters includesa plurality of assessment filters selected from the filters listed inTable 4. In one embodiment, the second plurality of assessment filtersincludes a kidney problem assessment filter and an electrolyte bloodlevel assessment filter.

In some embodiments, the first and second plurality of assessmentfilters includes filters selected from the filters listed in Table 8. Insome embodiments, the first plurality of assessment filters of the firstcategory class include a first sub-plurality of the filters listed inTable 8, for example, 2, 3, 4, 5, 6, or all 7 of the filters listed inTable 8, and the second plurality of assessment filters of the firstcategory class include a second sub-plurality of the filters listed inTable 8, which is different from the first sub-plurality of filters, forexample, 2, 3, 4, 5, 6, or all 7 of the filters listed in Table 8. Insome embodiments, each of the filters in the first sub-plurality offilters is different from each of the filters in the secondsub-plurality of filters (e.g., no filter listed in Table 8 is includedin both the first sub-plurality and the second sub-plurality offilters). In some embodiments, a system for qualifying a subject fordelivery of an over-the-counter angiotensin II receptor blockerpharmaceutical composition includes instructions for applying only oneplurality of filters, e.g., only filters of a single category class offilters. In some embodiments, where the method, system, or softwareapplies a single plurality of filters, the plurality of filters includesa plurality of filters selected from the filters listed in Table 8,e.g., at least 2, 3, 4, 5, 6, or all 7 of the filters listed in Table 8.In some embodiments, where a filter listed in Table 8 corresponds to afilter listed in Table 2 or Table 4, a threshold level sufficient tofire the corresponding filter listed in Table 2 or Table 4, as describedin detail above, is sufficient to fire the filter listed in Table 8.

TABLE 8 Example Assessment Filters Filter Exemplary Criteria 1b apregnancy assessment filter 2b a drug interaction assessment filter 3b ablood pressure assessment filter 4b an age assessment filter 5b a pooledcohort equation assessment filter 7b a kidney problem assessment filter8b an electrolyte blood level assessment filter

In one aspect, the disclosure provides methods, software, and computersystems for qualifying a human subject for a re-order (e.g., areassessment) for over-the-counter delivery of an angiotensin IIreceptor blocker pharmaceutical composition to lower blood pressure,e.g., treating or preventing heart disease. In one embodiment, acomputer system includes instructions, responsive to receiving are-order request from the subject for the angiotensin II receptorblocker pharmaceutical composition, performing a re-fulfillmentprocedure comprising conducting a reassessment survey of the subjectthereby obtaining a plurality of reassessment survey results necessaryto run against a first plurality of reassessment filters of a firstcategory class and a second plurality of reassessment filters of asecond category class. The method then includes running all or a portionof the plurality of reassessment survey results against a firstplurality of reassessment filters of a first category class, wherein,when a respective filter in the first plurality of reassessment filtersis fired, the subject is deemed not qualified for delivery of theangiotensin II receptor blocker pharmaceutical composition and themethod is terminated without delivery of the angiotensin II receptorblocker pharmaceutical composition to the subject. The method thenincludes running all or a portion of the plurality of assessment surveyresults against a second plurality of reassessment filters of a secondcategory class, wherein, when a respective filter in the secondplurality of reassessment filters is fired, the subject is provided witha warning corresponding to the respective filter. The method alsoincludes obtaining acknowledgment from the subject for the warningissued to the subject by any filter in the second plurality ofreassessment filters. The method also includes proceeding with are-fulfillment process when no filter in the first plurality ofreassessment filters has been fired and the subject has acknowledgedeach warning associated with each filter in the second plurality ofreassessment filters that was fired. The re-fulfillment processincludes: storing an indication in a subject profile of a re-order forthe angiotensin II receptor blocker pharmaceutical composition,communicating the over-the-counter drug facts label for the angiotensinII receptor blocker pharmaceutical composition to the subject, andauthorizing, upon confirmation from the subject that theover-the-counter drug facts label has been received and read, provisionof the angiotensin II receptor blocker pharmaceutical composition to thesubject.

In some embodiments, the first series of reassessment filters includesone or more filters listed in Table 6. In some embodiments, the firstplurality of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, and a kidney problem reassessment.

In some embodiments, the fourth series of filters includes one or morefilters listed in Table 7. In some embodiments, the fourth plurality offilters includes a renal function reassessment filter and/or a potassiumserum level reassessment filter.

In some embodiments, the first and second plurality of reassessmentfilters includes filters selected from the filters listed in Table 9. Insome embodiments, the first plurality of reassessment filters of thefirst category class include a first sub-plurality of the filters listedin Table 9, for example, 2, 3, 4, 5, or all 6 of the filters listed inTable 9, and the second plurality of reassessment filters of the firstcategory class include a second sub-plurality of the filters listed inTable 9, which is different from the first sub-plurality of filters, forexample, 2, 3, 4, 5, or all 6 of the filters listed in Table 9. In someembodiments, each of the filters in the first sub-plurality of filtersis different from each of the filters in the second sub-plurality offilters (e.g., no filter listed in Table 9 is included in both the firstsub-plurality and the second sub-plurality of filters). In someembodiments, a system for qualifying a subject for delivery of anover-the-counter angiotensin II receptor blocker pharmaceuticalcomposition includes instructions for applying only one plurality ofreassessment filters, e.g., only filters of a single category class offilters. In some embodiments, where the method, system, or softwareapplies a single plurality of reassessment filters, the plurality ofreassessment filters includes a plurality of reassessment filtersselected from the filters listed in Table 9, e.g., at least 2, 3, 4, 5,or all 6 of the filters listed in Table 9. In some embodiments, where afilter listed in Table 9 corresponds to a filter listed in Table 2,Table 4, Table 6, or Table 7, a threshold level sufficient to fire thecorresponding filter listed in Table 2, Table 4, Table 6, or Table 7, asdescribed in detail above, is sufficient to fire the filter listed inTable 9.

TABLE 9 Example Reassessment Filters Filter Exemplary Criteria 1b apregnancy reassessment filter 2b a blood pressure reassessment filter 3ba drug interaction reassessment filter 4b a hypotension reassessmentfilter 5b an electrolyte blood level reassessment filter 6b a kidneyproblem reassessment filter

In one aspect, the present disclosure provides a computer system forqualifying a human subject for over-the-counter delivery of angiotensinII receptor blocker pharmaceutical composition for lowering bloodpressure. The computer system includes one or more processors and amemory, the memory comprising non-transitory instructions which, whenexecuted by the one or more processor, perform a method. The methodincludes a) conducting an assessment survey of the subject therebyobtaining a plurality of assessment survey results. The plurality ofassessment survey results includes whether the subject is one of (i)pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,whether the subject is taking a medication that interacts with theangiotensin II receptor blocker pharmaceutical composition, a systolicblood pressure of the subject, a diastolic blood pressure of thesubject, an age of the subject, information required to calculate a riskof atherosclerotic cardiovascular disease for the subject, whether thesubject has ever had an abnormal electrolyte blood level, and whetherthe subject has ever had a kidney problem. The method further includesb) running all or a portion of the plurality of assessment surveyresults against a first plurality of assessment filters of a firstcategory class. When a respective filter in the first plurality ofassessment filters is fired, the subject is deemed not qualified fordelivery of the angiotensin II receptor blocker pharmaceuticalcomposition and the method is terminated without delivery of theangiotensin II receptor blocker pharmaceutical composition to thesubject. The first plurality of assessment filters includes a pregnancyassessment filter that is fired at least when the plurality ofassessment survey results indicates that the subject is pregnant or thesubject is breastfeeding, a drug interaction assessment filter that isfired at least when the plurality of assessment survey results indicatethat the subject is taking a medication that interacts with theangiotensin II receptor blocker pharmaceutical composition, a bloodpressure assessment filter that is fired at least when the plurality ofassessment survey results indicates the subject is not hypertensive orthe subject has severe hypertension, an age assessment filter that isfired at least when the plurality of assessment survey results indicatethe subject is too young to receive the angiotensin II receptor blockerpharmaceutical composition, and a pooled cohort equation assessmentfilter that is fired at least when the plurality of assessment surveyresults indicate that the subject has a risk for atheroscleroticcardiovascular disease that is below a floor threshold of risk or thesubject has an incalculable risk for atherosclerotic cardiovasculardisease. Further, the method includes c) running all or a portion of theplurality of assessment survey results against a second plurality ofassessment filters of a second category class. When a respective filterin the second plurality of assessment filters is fired, the subject isprovided with a warning corresponding to the respective filter. Thesecond plurality of assessment filters includes an electrolyte bloodlevel assessment filter that is fired at least when the plurality ofassessment survey results indicates that the subject has had an abnormalelectrolyte blood level, and a kidney problem assessment filter that isfired at least when the plurality of assessment survey results indicatesthat the subject has had a kidney problem. Furthermore, the methodincludes d) obtaining acknowledgment from the subject for the warningissued to the subject by any filter in the second plurality of filters.Additionally, the method includes e) proceeding with a fulfillmentprocess when (i) no filter in the first plurality of filters has beenfired and (ii) the subject has acknowledged each warning associated witheach filter in the second plurality of filters that was fired.Accordingly, the fulfillment process includes: storing an indication ina subject profile of an initial order for the angiotensin II receptorblocker pharmaceutical composition, communicating an over the counterdrug facts label for the angiotensin II receptor blocker pharmaceuticalcomposition to the subject, and authorizing, upon confirmation from thesubject that the over the counter drug facts label has been received andread, provision of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes an active ingredient having the structure:

where:

R1 is a group represented by the formula:

and

R2, R3, R4, R5, R6, R7, and R8 are each independently a hydrogen atom ora C1-6 alkyl, or a salt thereof.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes an active ingredient that is(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylateor a pharmaceutically acceptable salt thereof.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes an active ingredient that is azilsartan medoxomilor a pharmaceutically acceptable salt thereof.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 40 mg to 80 mg per day ofthe active ingredient of the angiotensin II receptor blockerpharmaceutical composition.

In some embodiments, the active ingredient of the angiotensin IIreceptor blocker pharmaceutical composition includes an activeingredient selected from the group consisting of candesartan,eprosartan, irbesartan, losartan, olmesartan, telmisartan, andvalsartan.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 4 mg to 32 mg ofcandesartan per day.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes candesartan. Accordingly, the plurality ofassessment survey results further includes whether the subject has aliver problem, and the first plurality of assessment filters includes aliver problem assessment filter that is fired at least when theplurality of assessment survey results indicates that the subject hasadvanced liver disease.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 400 mg to 800 mg ofeprosartan per day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage from 75 mg to 300 mg of irbesartanper day.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 25 mg to 100 mg of losartanper day.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes losartan. Accordingly, the plurality of assessmentsurvey results further includes whether the subject is taking apotassium supplement or a salt substitute that includes potassium, andthe second plurality of assessment filters includes a potassiumsupplement assessment filter that is fired at least when the pluralityof assessment survey results indicates that the subject is taking apotassium supplement or a salt substitute that includes potassium.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes losartan. Accordingly, the plurality of assessmentsurvey results further includes whether the subject has ever had a liverproblem, and the first plurality of assessment filters includes a liverproblem assessment filter that is fired at least when the plurality ofassessment survey results indicates that the subject has had a liverproblem.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 5 mg to 40 mg of olmesartanper day.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes olmesartan. Accordingly, the plurality ofassessment survey results further includes whether the subject is takingcolesevelam, and the second plurality of assessment filters includes acolesevelam interaction assessment filter that is fired at least whenthe plurality of assessment survey results indicates that the subject istaking colesevelam.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 20 mg to 80 mg oftelmisartan per day.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes telmisartan. Accordingly, the first druginteraction assessment filter is fired when the plurality of assessmentsurvey results indicates that the subject is taking digoxin.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes telmisartan. Accordingly, the plurality ofassessment survey results further includes whether the subject has everhad a liver problem, and the second plurality of assessment filtersincludes a liver problem assessment filter that is fired at least whenthe plurality of assessment survey results indicates that the subjecthas had a liver problem.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes telmisartan. Accordingly, the plurality ofassessment survey results further includes whether the subject is takinga potassium supplement or a salt substitute that includes potassium, andthe second plurality of assessment filters includes a potassiumsupplement assessment filter that is fired at least when the pluralityof assessment survey results indicates that the subject is taking apotassium supplement or a salt substitute that includes potassium.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes telmisartan. Accordingly, the plurality ofassessment survey results further includes whether the subject has everhad a heart failure, and the second plurality of assessment filtersincludes a heart failure assessment filter that is fired at least whenthe plurality of assessment survey results indicates that the subjecthas had a heart failure.

In some embodiments, upon confirmation from the subject that the overthe counter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 40 mg to 320 mg ofvalsartan per day.

In some embodiments, the pregnancy assessment filter is also fired whenthe plurality of assessment survey results indicates that the subject isplanning to become pregnant.

In some embodiments, the drug interaction assessment filter is firedwhen the plurality of assessment survey results indicates that thesubject is taking a lithium medication.

In some embodiments, the drug interaction assessment filter is firedwhen the plurality of assessment survey results indicates that thesubject is taking a non-steroidal anti-inflammatory medication.

In some embodiments, the drug interaction assessment filter is firedwhen the plurality of assessment survey results indicates that thesubject is taking a high blood pressure medication.

In some embodiments, a blood pressure that indicates the subject is nothypertensive, and is capable of firing the blood pressure assessmentfilter, is a systolic blood pressure of less than 130 mm Hg and adiastolic blood pressure of less than 80 mm Hg.

In some embodiments, a blood pressure that indicates the subject hassevere hypertension, and is capable of firing the blood pressureassessment filter, is a systolic blood pressure of at least 140 mm Hg ora diastolic blood pressure of at least 90 mm Hg.

In some embodiments, the performed method further includes, when theplurality of assessment survey results indicate that the subject haselevated blood pressure but is not hypertensive firing the bloodpressure assessment filter, and transmitting, to the subject, advice tomanage their blood pressure by eating healthy and exercising.

In some embodiments, the performed method further includes, when theplurality of assessment survey results indicate that the subject hasstage two hypertension firing the blood pressure assessment filter, andtransmitting, to the subject, advice to visit a doctor to discuss takinga prescription-strength blood pressure medication.

In some embodiments, the performed method further includes, when theplurality of assessment survey results indicate that the subject is inhypertensive crisis, firing the blood pressure assessment filter, andtransmitting, to the subject, advice to seek emergency medicalattention.

In some embodiments, the pooled cohort equation assessment filter isfired when the plurality of assessment survey results indicates that thesubject has a 10-year risk for atherosclerotic cardiovascular disease,as determined using the pooled cohort equation, that is less than 10%.

In some embodiments, the pooled cohort equation assessment filter isfired when the plurality of assessment survey results indicates that thesubject has an incalculable risk for atherosclerotic cardiovasculardisease, as determined by one or more inputs of the pooled cohortequation, including: A) the subject is younger than forty years old, B)a total cholesterol level of the subject is either less than 160 mg/dLor greater than 240 mg/dL, C) a high density lipoprotein cholesterollevel of the subject is less than 45 mg/dL or greater than 65 mg/dL, D)an untreated systolic blood pressure of the subject is less than 100 mmHg or greater than 140 mm Hg, or E) a treated systolic blood pressure ofthe subject is less than 120 mm Hg or greater than 160 mm Hg.

In some embodiments, the method includes bypassing the firing of thepooled cohort equation assessment filter when the plurality ofassessment survey results indicates that the subject has an incalculablerisk for atherosclerotic cardiovascular disease but has an age that isabove a risk threshold age.

In some embodiments, the plurality of assessment survey results furtherincludes a gender of the subject, an age of the subject, a race of thesubject, a blood pressure medication status of the subject, a smokingstatus of the subject, a total cholesterol level of the subject, a highdensity lipoprotein cholesterol level of the subject, whether thesubject has ever had an atherosclerotic cardiovascular history includingan atherosclerotic cardiovascular event or a heart procedure, and adiabetes status of the subject. The pooled cohort equation assessmentfilter incorporates the gender of the subject, the age of the subject,the race of the subject, the blood pressure medication status of thesubject, the smoking status of the subject, the total cholesterol of thesubject, the high density lipoprotein cholesterol level of the subject,the atherosclerotic cardiovascular history of the subject, and thediabetes status of the subject to derive the risk for atheroscleroticcardiovascular disease.

In some embodiments, the pooled cohort equation is implemented as amultivariable Cox proportional hazard regression.

In some embodiments, the plurality of assessment survey results furtherincludes whether the subject is allergic to the angiotensin II receptorblock pharmaceutical composition, and the first plurality of assessmentfilters includes an adverse reaction assessment filter that is firedwhen the plurality of assessment survey results indicates that thesubject is allergic to the angiotensin II receptor blockerpharmaceutical composition.

In some embodiments, the warning corresponding to a respective filter inthe second plurality of assessment filters includes a prompt for thesubject to indicate whether they have discussed the risk factorunderlying the respective filter in the second plurality of assessmentfilters that was fired with a health care provider. Accordingly,acknowledgement is obtained from the subject when the subject indicatesthat they have discussed the risk factor underlying the respectivefilter in the second plurality of assessment filters that was fired witha health care provider.

In some embodiments, the fulfillment process further includes storing adestination associated with the subject in the subject profile.

In some embodiments, the fulfillment process further includescoordinating shipping of the angiotensin II receptor blockerpharmaceutical composition to a physical address associated with thesubject.

In some embodiments, the lowering blood pressure is to treat or preventa heart disease.

Another aspect of the present disclosure provides a computer system forrequalifying a human subject for over-the-counter delivery of anangiotensin II receptor blocker pharmaceutical composition for loweringblood pressure. The computer system comprising one or more processorsand a memory, the memory comprising non-transitory instructions which,when executed by the one or more processor, perform a re-fulfillmentmethod comprising, responsive to receiving a re-order request from thesubject for the angiotensin II receptor blocker pharmaceuticalcomposition, (a) conducting a reassessment survey of the subject therebyobtaining a plurality of reassessment survey results. The plurality ofreassessment survey results includes a systolic blood pressure of thesubject, a diastolic blood pressure of the subject, whether the subjectis one of (i) pregnant, (ii) breastfeeding, or (iii) planning to becomepregnant, whether the subject is taking a medication that interacts withthe angiotensin II receptor blocker pharmaceutical composition, whetherthe subject has experienced symptoms of hypotension since receivingtheir last provision of the angiotensin II receptor blockerpharmaceutical composition, whether the subject has developed anabnormal electrolyte blood level since receiving their last provision ofthe angiotensin II receptor blocker pharmaceutical composition, andwhether the subject has developed a kidney problem since receiving theirlast provision of the angiotensin II receptor blocker pharmaceuticalcomposition. Further, the method includes (b) running all or a portionof the plurality of reassessment survey results against a firstplurality of reassessment filters of a first category class. When arespective filter in the first plurality of reassessment filters isfired, the subject is deemed not qualified for the angiotensin IIreceptor blocker pharmaceutical composition and the re-fulfillmentprocess is terminated without delivery of the angiotensin II receptorblocker pharmaceutical composition to the subject. The first pluralityof reassessment filters include a blood pressure reassessment filterthat is fired at least when the plurality of reassessment survey resultsindicates the subject has hypertension, a pregnancy reassessment filterthat is fired at least when the plurality of reassessment survey resultsindicates the subject is pregnant or the subject is breastfeeding, adrug interaction reassessment filter that is fired at least when theplurality of reassessment survey results indicates the subject is takinga medication that interacts with the angiotensin II receptor blockerpharmaceutical composition, a hypotension reassessment filter that isfired at least when the plurality of reassessment survey resultsindicates that the subject has experienced symptoms of hypotension sincereceiving their last provision of the angiotensin II receptor blockerpharmaceutical composition, an electrolyte blood level reassessmentfilter that is fired at least when the plurality of reassessment surveyresults indicates that the subject has developed an abnormal electrolyteblood level since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition, and a kidney problemreassessment filter that is fired at least when the plurality ofreassessment survey results indicates that the subject has developed akidney problem since receiving their last provision of the angiotensinII receptor blocker pharmaceutical composition. Additionally, the methodincludes (c) proceeding with the re-fulfillment when (a) there-fulfillment is not already terminated by the firing of a filter inthe first plurality of reassessment filters. The re-fulfillment furtherincludes storing an indication in the subject profile of a re-order forthe angiotensin II receptor blocker pharmaceutical composition,communicating the over the counter drug facts label for the angiotensinII receptor blocker pharmaceutical composition to the subject, andauthorizing, upon confirmation from the subject that the over thecounter drug facts label has been received and read, a re-orderprovision of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition is selected from the group consisting of azilsartanmedoxomil, candesartan, eprosartan, irbesartan, losartan, olmesartan,telmisartan, and valsartan.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes irbesartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an impaired renal function since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process includes running all or aportion of the plurality of reassessment survey results against a renalfunction reassessment filter of a second category class that is fired atleast when the plurality of reassessment survey results indicates thatthe subject has experienced, since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition, an impairedrenal function, wherein when the renal function reassessment filter isfired, the subject is provided with a warning corresponding to the renalfunction reassessment filter.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes irbesartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an abnormal potassium serum level since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process further includes running allor a portion of the plurality of reassessment survey results against apotassium serum level reassessment filter of the second category classthat is fired at least when the plurality of reassessment survey resultsindicates that the subject has experienced, since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, an abnormal potassium serum level, wherein when the serumpotassium level reassessment filter is fired, the subject is providedwith a warning corresponding to the serum potassium level reassessmentfilter.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes losartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an impaired renal function since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process includes running all or aportion of the plurality of reassessment survey results against a renalfunction reassessment filter of a second category class that is fired atleast when the plurality of reassessment survey results indicates thatthe subject has experienced, since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition, an impairedrenal function, wherein when the renal function reassessment filter isfired, the subject is provided with a warning corresponding to the renalfunction reassessment filter.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes losartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an abnormal potassium serum level since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process further includes running allor a portion of the plurality of reassessment survey results against apotassium serum level reassessment filter of the second category classthat is fired at least when the plurality of reassessment survey resultsindicates that the subject has experienced, since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, an abnormal potassium serum level, wherein when the serumpotassium level reassessment filter is fired, the subject is providedwith a warning corresponding to the serum potassium level reassessmentfilter.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes telmisartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an impaired renal function since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process includes running all or aportion of the plurality of reassessment survey results against a renalfunction reassessment filter of a second category class that is fired atleast when the plurality of reassessment survey results indicates thatthe subject has experienced, since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition, an impairedrenal function, wherein when the renal function reassessment filter isfired, the subject is provided with a warning corresponding to the renalfunction reassessment filter.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes telmisartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an abnormal potassium serum level since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process further includes running allor a portion of the plurality of reassessment survey results against apotassium serum level reassessment filter of the second category classthat is fired at least when the plurality of reassessment survey resultsindicates that the subject has experienced, since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, an abnormal potassium serum level, wherein when the serumpotassium level reassessment filter is fired, the subject is providedwith a warning corresponding to the serum potassium level reassessmentfilter.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes valsartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an impaired renal function since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process includes running all or aportion of the plurality of reassessment survey results against a renalfunction reassessment filter of a second category class that is fired atleast when the plurality of reassessment survey results indicates thatthe subject has experienced, since receiving their last provision of theangiotensin II receptor blocker pharmaceutical composition, an impairedrenal function, wherein when the renal function reassessment filter isfired, the subject is provided with a warning corresponding to the renalfunction reassessment filter.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes valsartan. Accordingly, the plurality ofreassessment survey results further includes whether the subject hasexperienced an abnormal potassium serum level since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, and the re-fulfillment process further includes running allor a portion of the plurality of reassessment survey results against apotassium serum level reassessment filter of the second category classthat is fired at least when the plurality of reassessment survey resultsindicates that the subject has experienced, since receiving their lastprovision of the angiotensin II receptor blocker pharmaceuticalcomposition, an abnormal potassium serum level, wherein when the serumpotassium level reassessment filter is fired, the subject is providedwith a warning corresponding to the serum potassium level reassessmentfilter.

In some embodiments, the pregnancy reassessment filter is also firedwhen the plurality of reassessment survey results indicates that thesubject is planning to become pregnant.

In some embodiments, the drug interaction reassessment filter is firedwhen the plurality of reassessment survey results indicates that thesubject is taking a lithium medication.

In some embodiments, the drug interaction reassessment filter is firedwhen the plurality of reassessment survey results indicates that thesubject is taking a non-steroidal anti-inflammatory medication.

In some embodiments, the drug interaction reassessment filter is firedwhen the plurality of reassessment survey results indicates that thesubject is taking a high blood pressure medication.

In some embodiments, the plurality of reassessment survey resultsfurther includes whether the subject has experienced a side effectassociated with the angiotensin II receptor blocker pharmaceuticalcomposition since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition, and the re-fulfillmentprocess further includes running all or a portion of the plurality ofreassessment survey results against a side effect reassessment filter ofa second category class that is fired at least when plurality ofreassessment survey results indicates that the subject has experienced,since receiving their last provision of the angiotensin II receptorblocker pharmaceutical composition, a side effect selected from thegroup consisting of hypotension, dizziness, and faintness, wherein whenthe side effect reassessment filter is fired, the subject is providedwith a warning corresponding to the side effect reassessment filter.

In some embodiments, the re-fulfillment process further includes, when arespective filter in the first plurality of reassessment filters orsecond plurality of reassessment filters is fired, storing a recordassociated with the firing of the respective filter in an adverse eventprofile comprising records of filter firing events associated with aplurality of subjects.

In some embodiments, the lowering blood pressure is to treat or preventa heart disease.

In one aspect, a method is provided for lowering blood pressure in asubject in need thereof. The method includes administering anangiotensin II receptor blocker pharmaceutical composition to a subjectqualified for over-the-counter access to the angiotensin II receptorblocker pharmaceutical composition. In some embodiments, the subject isqualified using a method and/or system as described herein.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes an active ingredient having the structure:

where:

R1 is a group represented by the formula:

and

R2, R3, R4, R5, R6, R7, and R8 are each independently a hydrogen atom ora C1-6 alkyl, or a salt thereof.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes an active ingredient that is(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylateor a pharmaceutically acceptable salt thereof.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition includes an active ingredient that is azilsartan medoxomilor a pharmaceutically acceptable salt thereof.

In some embodiments, the subject is administered from 40 mg to 80 mg ofthe active ingredient of the angiotensin II receptor blockerpharmaceutical composition per day.

In some embodiments, the angiotensin II receptor blocker pharmaceuticalcomposition comprises an active ingredient that is selected from thegroup consisting of candesartan, eprosartan, irbesartan, losartan,olmesartan, telmisartan, and valsartan. In some embodiments, the subjectis administered from 4 mg to 32 mg of candesartan per day. In someembodiments, the subject is administered from 400 mg to 800 mg ofeprosartan per day. In some embodiments, the subject is administeredfrom 75 mg to 300 mg of irbesartan per day. In some embodiments, thesubject is administered from 25 mg to 100 mg of losartan per day. Insome embodiments, the subject is administered from 5 mg to 40 mg ofolmesartan per day. In some embodiments, the subject is administeredfrom 20 mg to 80 mg of telmisartan per day. In some embodiments, thesubject is administered from 40 mg to 320 mg of valsartan per day.

In some embodiments, the disclosure provides methods for lowering bloodpressure with an over the counter angiotensin II receptor blockerpharmaceutical composition. The method includes providing a first surveyfor obtaining a first information set from the human, via a computersystem having a processor programmed to perform the first survey, wherethe first information set includes information about the human thatrelates to potential risk factors and contraindications for theangiotensin II receptor blocker pharmaceutical composition, as describedherein. The method also includes applying an algorithm to the firstinformation set, via a computer system having a processor programmed toperform the algorithm. The algorithm runs all or a portion of the firstinformation set against a first plurality of filters, where the human isdeemed not qualified for treatment with the over the counter angiotensinII receptor blocker pharmaceutical composition for lowering bloodpressure when a respective filter in the first plurality of filters isfired and the method is terminated without authorizing provision of theangiotensin II receptor blocker pharmaceutical composition to the human,where the first plurality of filters includes filters related tocontraindications of the angiotensin II receptor blocker pharmaceuticalcomposition as described herein. The algorithm also runs all or aportion of the first information set against a second plurality offilters, where, when a respective filter in the second plurality offilters is fired, the human is provided with a warning corresponding tothe respective filter, and where the second plurality of filtersincludes filters related to risk factors for the angiotensin II receptorblocker pharmaceutical composition as described herein. The algorithmalso obtains acknowledgment from the human of the risk factor associatedwith each warning issued to the human by any filter in the secondplurality of filters. In some embodiments, the acknowledgement includesconfirmation that the human has discussed the risk factor with aphysician. The algorithm proceeds with a fulfillment process when (a) nofilter in the first plurality of filters has been fired and (b) thehuman has acknowledged each warning associated with each filter in thesecond plurality of filters that was fired. The fulfillment processincludes storing an indication in a subject profile of an initial orderfor the angiotensin II receptor blocker pharmaceutical composition,communicating an over the counter drug facts label for the angiotensinII receptor blocker pharmaceutical composition to the human, andauthorizing, upon confirmation from the subject that the over thecounter drug facts label has been received and read, provision of theangiotensin II receptor blocker pharmaceutical composition to the human,where the authorization includes a destination associated with thesubject. In some embodiments, the method also includes treating thehuman to lower the blood pressure of the human, upon authorization ofthe provision e.g., by providing access to the angiotensin II receptorblocker pharmaceutical composition to the human and/or by administeringthe angiotensin II receptor blocker pharmaceutical composition to lowerblood pressure in the human.

EXAMPLES Example 1—Azilsartan

A computer system is configured for qualifying a subject forover-the-counter delivery of an azilsartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the azilsartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, and whether the subject has everhad a kidney problem.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the azilsartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter azilsartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter,and a pooled cohort equation assessment filter, configured to be firedas described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter azilsartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter and a kidneyproblem assessment filter, configured to be fired as described above.The computer is configured to prompt the subject to acknowledge havingdiscussed any warnings that are triggered with a medical professional(e.g., their physician or healthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC azilsartan in a subjectprofile, and communicates an over-the-counter drug facts label for theazilsartan pharmaceutical composition to the subject. Upon confirmationby the subject that they have received and read the over-the-counterdrug facts label, the computer system is configured to authorizeprovision of the OTC azilsartan pharmaceutical composition to thesubject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the azilsartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for theazilsartan pharmaceutical composition by the subject. The reassessmentsurvey is utilized to obtain one or more results of: a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject is one of pregnant, breastfeeding, or planning tobecome pregnant, whether the subject is taking a substance thatinteracts with the azilsartan pharmaceutical composition, whether thesubject has experienced symptoms of hypotension since receiving theirlast provision of the azilsartan pharmaceutical composition, whether thesubject has developed an abnormal electrolyte blood level sincereceiving their last provision of the azilsartan pharmaceuticalcomposition, and whether the subject has developed a kidney problemsince receiving their last provision of the azilsartan pharmaceuticalcomposition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, and a kidney problem reassessment filter,configured to be fired as described above.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired. Thecomputer system stores an indication of a re-order of the OTC azilsartanin the subject profile, and communicates an over-the-counter drug factslabel for the azilsartan pharmaceutical composition to the subject. Uponconfirmation by the subject that they have received and read theover-the-counter drug facts label, the computer system is configured toauthorize provision of the OTC azilsartan pharmaceutical composition tothe subject.

Example 2—Candesartan

A computer system is configured for qualifying a subject forover-the-counter delivery of a candesartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the candesartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, whether the subject has ever had akidney problem, and whether the subject has ever had a liver problem.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the candesartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter candesartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter, apooled cohort equation assessment filter, and a liver disease filter,configured to be fired as described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter candesartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter and a kidneyproblem assessment filter, configured as described above. The computeris configured to prompt the subject to acknowledge having discussed anywarnings that are triggered with a medical professional (e.g., theirphysician or healthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC candesartan in a subjectprofile, and communicates an over-the-counter drug facts label for thecandesartan pharmaceutical composition to the subject. Upon confirmationby the subject that they have received and read the over-the-counterdrug facts label, the computer system is configured to authorizeprovision of the OTC candesartan pharmaceutical composition to thesubject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the candesartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for thecandesartan pharmaceutical composition by the subject. The reassessmentsurvey is utilized to obtain one or more results of: a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject is one of pregnant, breastfeeding, or planning tobecome pregnant, whether the subject is taking a substance thatinteracts with the candesartan pharmaceutical composition, whether thesubject has experienced symptoms of hypotension since receiving theirlast provision of the candesartan pharmaceutical composition, whetherthe subject has developed an abnormal electrolyte blood level sincereceiving their last provision of the candesartan pharmaceuticalcomposition, whether the subject has developed a kidney problem sincereceiving their last provision of the candesartan pharmaceuticalcomposition, and whether the subject has developed a liver problem sincereceiving their last provision of the candesartan pharmaceuticalcomposition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, a kidney problem reassessment filter, and a liverdisease reassessment filter, configured as described above.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired. Thecomputer system stores an indication of a re-order of the OTCcandesartan in the subject profile, and communicates an over-the-counterdrug facts label for the candesartan pharmaceutical composition to thesubject. Upon confirmation by the subject that they have received andread the over-the-counter drug facts label, the computer system isconfigured to authorize provision of the OTC candesartan pharmaceuticalcomposition to the subject.

Example 3—Eprosartan

A computer system is configured for qualifying a subject forover-the-counter delivery of an eprosartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the eprosartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, and whether the subject has everhad a kidney problem.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the eprosartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter eprosartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter,and a pooled cohort equation assessment filter, configured to be firedas described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter eprosartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter and a kidneyproblem assessment filter, configured as described above. The computeris configured to prompt the subject to acknowledge having discussed anywarnings that are triggered with a medical professional (e.g., theirphysician or healthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC eprosartan in a subjectprofile, and communicates an over-the-counter drug facts label for theeprosartan pharmaceutical composition to the subject. Upon confirmationby the subject that they have received and read the over-the-counterdrug facts label, the computer system is configured to authorizeprovision of the OTC eprosartan pharmaceutical composition to thesubject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the eprosartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for theeprosartan pharmaceutical composition by the subject. The reassessmentsurvey is utilized to obtain one or more results of: a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject is one of pregnant, breastfeeding, or planning tobecome pregnant, whether the subject is taking a substance thatinteracts with the eprosartan pharmaceutical composition, whether thesubject has experienced symptoms of hypotension since receiving theirlast provision of the eprosartan pharmaceutical composition, whether thesubject has developed an abnormal electrolyte blood level sincereceiving their last provision of the eprosartan pharmaceuticalcomposition, and whether the subject has developed a kidney problemsince receiving their last provision of the eprosartan pharmaceuticalcomposition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, and a kidney problem reassessment filter,configured as described above.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired. Thecomputer system stores an indication of a re-order of the OTC eprosartanin the subject profile, and communicates an over-the-counter drug factslabel for the eprosartan pharmaceutical composition to the subject. Uponconfirmation by the subject that they have received and read theover-the-counter drug facts label, the computer system is configured toauthorize provision of the OTC eprosartan pharmaceutical composition tothe subject.

Example 4—Irbesartan

A computer system is configured for qualifying a subject forover-the-counter delivery of an irbesartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the irbesartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, whether the subject has ever had akidney problem, and whether the subject is taking a supplementcontaining potassium.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the irbesartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter irbesartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter,and a pooled cohort equation assessment filter, configured to be firedas described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter irbesartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter, a kidney problemassessment filter, and a potassium supplement assessment filter,configured to be fired as described above. The computer is configured toprompt the subject to acknowledge having discussed any warnings that aretriggered with a medical professional (e.g., their physician orhealthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC irbesartan in a subjectprofile, and communicates an over-the-counter drug facts label for theirbesartan pharmaceutical composition to the subject. Upon confirmationby the subject that they have received and read the over-the-counterdrug facts label, the computer system is configured to authorizeprovision of the OTC irbesartan pharmaceutical composition to thesubject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the irbesartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for theirbesartan pharmaceutical composition by the subject. The reassessmentsurvey is utilized to obtain one or more results of: a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject is one of pregnant, breastfeeding, or planning tobecome pregnant, whether the subject is taking a substance thatinteracts with the irbesartan pharmaceutical composition, whether thesubject has experienced symptoms of hypotension since receiving theirlast provision of the irbesartan pharmaceutical composition, whether thesubject has developed an abnormal electrolyte blood level sincereceiving their last provision of the irbesartan pharmaceuticalcomposition, whether the subject has developed a kidney problem sincereceiving their last provision of the irbesartan pharmaceuticalcomposition, and whether the subject has begun taking a supplementcontaining potassium since receiving their last provision of theirbesartan pharmaceutical composition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, and a kidney problem reassessment filter,configured as described above.

The computer system is configured to run reassessment survey resultsagainst a potassium supplement filter associated with the second filtercategory class.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired and thesubject has acknowledged each warning associated with second series ofreassessment filters that are fired. The computer system stores anindication of a re-order of the OTC irbesartan in the subject profile,and communicates an over-the-counter drug facts label for the irbesartanpharmaceutical composition to the subject. Upon confirmation by thesubject that they have received and read the over-the-counter drug factslabel, the computer system is configured to authorize provision of theOTC irbesartan pharmaceutical composition to the subject.

Example 5—Losartan

A computer system is configured for qualifying a subject forover-the-counter delivery of an losartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the losartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, whether the subject has ever had akidney problem, whether the subject has ever had liver problems, andwhether the subject is taking a supplement containing potassium.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the losartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter losartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter, apooled cohort equation assessment filter, and a liver disease filter,configured to be fired as described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter losartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter, a kidney problemassessment filter, and a potassium supplement assessment filter,configured to be fired as described above. The computer is configured toprompt the subject to acknowledge having discussed any warnings that aretriggered with a medical professional (e.g., their physician orhealthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC losartan in a subject profile,and communicates an over-the-counter drug facts label for the losartanpharmaceutical composition to the subject. Upon confirmation by thesubject that they have received and read the over-the-counter drug factslabel, the computer system is configured to authorize provision of theOTC losartan pharmaceutical composition to the subject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the losartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for the losartanpharmaceutical composition by the subject. The reassessment survey isutilized to obtain one or more results of: a systolic blood pressure ofthe subject, a diastolic blood pressure of the subject, whether thesubject is one of pregnant, breastfeeding, or planning to becomepregnant, whether the subject is taking a substance that interacts withthe losartan pharmaceutical composition, whether the subject hasexperienced symptoms of hypotension since receiving their last provisionof the losartan pharmaceutical composition, whether the subject hasdeveloped an abnormal electrolyte blood level since receiving their lastprovision of the losartan pharmaceutical composition, whether thesubject has developed a kidney problem since receiving their lastprovision of the losartan pharmaceutical composition, whether thesubject has developed a liver problem since receiving their lastprovision of the losartan pharmaceutical composition, and whether thesubject has begun taking a supplement containing potassium sincereceiving their last provision of the losartan pharmaceuticalcomposition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelmonitor reassessment filter, a kidney problem reassessment filter, and aliver disease reassessment filter, configured as described above.

The computer system is configured to run reassessment survey resultsagainst a potassium supplement filter associated with the second filtercategory class.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired and thesubject has acknowledged each warning associated with second series ofreassessment filters that are fired. The computer system stores anindication of a re-order of the OTC losartan in the subject profile, andcommunicates an over-the-counter drug facts label for the losartanpharmaceutical composition to the subject. Upon confirmation by thesubject that they have received and read the over-the-counter drug factslabel, the computer system is configured to authorize provision of theOTC losartan pharmaceutical composition to the subject.

Example 6—Olmesartan

A computer system is configured for qualifying a subject forover-the-counter delivery of an olmesartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the olmesartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, whether the subject has ever had akidney problem, and whether the subject is taking colesevelam.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the olmesartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter olmesartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter,and a pooled cohort equation assessment filter, configured to be firedas described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter olmesartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter, a kidney problemassessment filter, and a colesevelam filter, configured to be fired asdescribed above. The computer is configured to prompt the subject toacknowledge having discussed any warnings that are triggered with amedical professional (e.g., their physician or healthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC olmesartan in a subjectprofile, and communicates an over-the-counter drug facts label for theolmesartan pharmaceutical composition to the subject. Upon confirmationby the subject that they have received and read the over-the-counterdrug facts label, the computer system is configured to authorizeprovision of the OTC olmesartan pharmaceutical composition to thesubject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the olmesartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for theolmesartan pharmaceutical composition by the subject. The reassessmentsurvey is utilized to obtain one or more results of: a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject is one of pregnant, breastfeeding, or planning tobecome pregnant, whether the subject is taking a substance thatinteracts with the olmesartan pharmaceutical composition, whether thesubject has experienced symptoms of hypotension since receiving theirlast provision of the olmesartan pharmaceutical composition, whether thesubject has developed an abnormal electrolyte blood level sincereceiving their last provision of the olmesartan pharmaceuticalcomposition, whether the subject has developed a kidney problem sincereceiving their last provision of the olmesartan pharmaceuticalcomposition, and whether the subject has begun taking colesevelam sincereceiving their last provision of the olmesartan pharmaceuticalcomposition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, and a kidney problem reassessment filter,configured to be fired as described above.

The computer system is configured to run reassessment survey resultsagainst a colesevelam filter associated with the second filter categoryclass.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired. Thecomputer system stores an indication of a re-order of the OTC olmesartanin the subject profile, and communicates an over-the-counter drug factslabel for the olmesartan pharmaceutical composition to the subject. Uponconfirmation by the subject that they have received and read theover-the-counter drug facts label, the computer system is configured toauthorize provision of the OTC olmesartan pharmaceutical composition tothe subject.

Example 7—Telmisartan

A computer system is configured for qualifying a subject forover-the-counter delivery of a telmisartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the telmisartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, whether the subject has ever had akidney problem, and whether the subject has ever had a liver problem.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the telmisartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter telmisartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter, apooled cohort equation assessment filter, and a liver disease filter,configured to be fired as described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter telmisartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter and a kidneyproblem assessment filter, configured as described above. The computeris configured to prompt the subject to acknowledge having discussed anywarnings that are triggered with a medical professional (e.g., theirphysician or healthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC telmisartan in a subjectprofile, and communicates an over-the-counter drug facts label for thetelmisartan pharmaceutical composition to the subject. Upon confirmationby the subject that they have received and read the over-the-counterdrug facts label, the computer system is configured to authorizeprovision of the OTC telmisartan pharmaceutical composition to thesubject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the telmisartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for thetelmisartan pharmaceutical composition by the subject. The reassessmentsurvey is utilized to obtain one or more results of: a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject is one of pregnant, breastfeeding, or planning tobecome pregnant, whether the subject is taking a substance thatinteracts with the telmisartan pharmaceutical composition, whether thesubject has experienced symptoms of hypotension since receiving theirlast provision of the telmisartan pharmaceutical composition, whetherthe subject has developed an abnormal electrolyte blood level sincereceiving their last provision of the telmisartan pharmaceuticalcomposition, whether the subject has developed a kidney problem sincereceiving their last provision of the telmisartan pharmaceuticalcomposition, and whether the subject has developed a liver problem sincereceiving their last provision of the telmisartan pharmaceuticalcomposition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, a kidney problem reassessment filter, and a liverdisease reassessment filter, configured as described above.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired. Thecomputer system stores an indication of a re-order of the OTCtelmisartan in the subject profile, and communicates an over-the-counterdrug facts label for the telmisartan pharmaceutical composition to thesubject. Upon confirmation by the subject that they have received andread the over-the-counter drug facts label, the computer system isconfigured to authorize provision of the OTC telmisartan pharmaceuticalcomposition to the subject.

Example 8—Valsartan

A computer system is configured for qualifying a subject forover-the-counter delivery of a valsartan pharmaceutical composition totreat or prevent heart disease (e.g., by lowering blood pressure). Thecomputer system includes instructions for conducting an assessmentsurvey of the subject. The assessment survey is used to obtain one ormore of the following results of: whether the subject is one ofpregnant, breastfeeding, or planning to become pregnant, whether thesubject is taking a medication that interacts with the valsartanpharmaceutical composition, a systolic blood pressure of the subject, adiastolic blood pressure of the subject, an age of the subject,information required to calculate a risk of atheroscleroticcardiovascular disease for the subject, whether the subject has ever hadan abnormal electrolyte blood level, and whether the subject has everhad a kidney problem.

The computer system is configured to run assessment survey resultsagainst a first series of assessment filters that are each associatedwith a first filter category class. The filters of the first filtercategory class are configured to prevent authorization for OTC deliveryof the valsartan pharmaceutical composition when the assessment surveyresults indicate the presence of a contraindication for administrationof over-the-counter valsartan. The first series of assessment filtersincludes a pregnancy assessment filter, a drug interaction assessmentfilter, a blood pressure assessment filter, an age assessment filter,and a pooled cohort equation assessment filter, configured to be firedas described above.

The computer system is configured to run assessment survey resultsagainst a second series of assessment filters that are each associatedwith a second filter category class. The filters of the second categoryfilter class are configured to generate a warning when the assessmentsurvey results indicate the presence of a risk factor for administrationof over-the-counter valsartan. The second series of assessment filtersincludes an electrolyte blood level assessment filter and a kidneyproblem assessment filter, configured to be fired as described above.The computer is configured to prompt the subject to acknowledge havingdiscussed any warnings that are triggered with a medical professional(e.g., their physician or healthcare provider).

The computer system is configured to proceed with a fulfillment processonly when none of the first series of assessment filters are fired andthe subject has acknowledged each warning associated with second seriesof assessment filters that are fired. The computer system stores anindication of an initial order of the OTC valsartan in a subjectprofile, and communicates an over-the-counter drug facts label for thevalsartan pharmaceutical composition to the subject. Upon confirmationby the subject that they have received and read the over-the-counterdrug facts label, the computer system is configured to authorizeprovision of the OTC valsartan pharmaceutical composition to thesubject.

In some embodiments, the computer system includes instructions forqualifying a subject for a re-order provision of the valsartanpharmaceutical composition. The computer system is configured to conducta reassessment survey responsive to a re-order request for the valsartanpharmaceutical composition by the subject. The reassessment survey isutilized to obtain one or more results of: a systolic blood pressure ofthe subject, a diastolic blood pressure of the subject, whether thesubject is one of pregnant, breastfeeding, or planning to becomepregnant, whether the subject is taking a substance that interacts withthe valsartan pharmaceutical composition, whether the subject hasexperienced symptoms of hypotension since receiving their last provisionof the valsartan pharmaceutical composition, whether the subject hasdeveloped an abnormal electrolyte blood level since receiving their lastprovision of the valsartan pharmaceutical composition, and whether thesubject has developed a kidney problem since receiving their lastprovision of the valsartan pharmaceutical composition.

The computer system is configured to run reassessment survey resultsagainst a first series of reassessment filters that are each associatedwith the first filter category class. In some embodiments, the firstseries of reassessment filters includes a blood pressure reassessmentfilter, a pregnancy reassessment filter, a drug interaction reassessmentfilter, a hypotension reassessment filter, an electrolyte blood levelreassessment filter, and a kidney problem reassessment filter,configured to be fired as described above.

The computer system then proceeds with a re-fulfillment process onlywhen none of the first series of reassessment filters are fired. Thecomputer system stores an indication of a re-order of the OTC valsartanin the subject profile, and communicates an over-the-counter drug factslabel for the valsartan pharmaceutical composition to the subject. Uponconfirmation by the subject that they have received and read theover-the-counter drug facts label, the computer system is configured toauthorize provision of the OTC valsartan pharmaceutical composition tothe subject.

REFERENCES CITED AND ALTERNATIVE EMBODIMENTS

All references cited herein are incorporated herein by reference intheir entirety and for all purposes to the same extent as if eachindividual publication or patent or patent application was specificallyand individually indicated to be incorporated by reference in itsentirety for all purposes.

The present invention can be implemented as a computer program productthat includes a computer program mechanism embedded in a non-transitorycomputer readable storage medium. For instance, the computer programproduct could contain the program modules shown in any combination ofFIGS. 1, 2, and 3 and/or described in FIG. 4 or 5. These program modulescan be stored on a CD-ROM, DVD, magnetic disk storage product, USB key,or any other non-transitory computer readable data or program storageproduct.

Many modifications and variations of this invention can be made withoutdeparting from its spirit and scope, as will be apparent to thoseskilled in the art. The specific embodiments described herein areoffered by way of example only. The embodiments were chosen anddescribed in order to best explain the principles of the invention andits practical applications, to thereby enable others skilled in the artto best utilize the invention and various embodiments with variousmodifications as are suited to the particular use contemplated. Theinvention is to be limited only by the terms of the appended claims,along with the full scope of equivalents to which such claims areentitled.

1. A computer system for qualifying a human subject for over-the-counterdelivery of an angiotensin II receptor blocker pharmaceuticalcomposition for lowering blood pressure, the computer system comprisingone or more processors and a memory, the memory comprisingnon-transitory instructions which, when executed by the one or moreprocessor, cause the computer system to perform a method comprising: a)conducting an assessment survey of the subject thereby obtaining aplurality of assessment survey results, wherein the plurality ofassessment survey results comprises: whether the subject is one of (i)pregnant, (ii) breastfeeding, or (iii) planning to become pregnant,whether the subject is taking a medication that interacts with theangiotensin II receptor blocker pharmaceutical composition, a systolicblood pressure of the subject, a diastolic blood pressure of thesubject, an age of the subject, information required to calculate a riskof atherosclerotic cardiovascular disease for the subject, whether thesubject has ever had an abnormal electrolyte blood level, and whetherthe subject has ever had a kidney problem; b) running all or a portionof the plurality of assessment survey results against a first pluralityof assessment filters of a first category class, wherein, when arespective filter in the first plurality of assessment filters is fired,the subject is deemed not qualified for delivery of the angiotensin IIreceptor blocker pharmaceutical composition and the method is terminatedwithout delivery of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject, wherein the first plurality of assessmentfilters comprises: a pregnancy assessment filter that is fired at leastwhen the plurality of assessment survey results indicates that thesubject is pregnant or the subject is breastfeeding, a drug interactionassessment filter that is fired at least when the plurality ofassessment survey results indicate that the subject is taking amedication that interacts with the angiotensin II receptor blockerpharmaceutical composition, a blood pressure assessment filter that isfired at least when the plurality of assessment survey results indicatesthe subject is not hypertensive or the subject has severe hypertension,an age assessment filter that is fired at least when the plurality ofassessment survey results indicate the subject is too young to receivethe angiotensin II receptor blocker pharmaceutical composition, and apooled cohort equation assessment filter that is fired at least when theplurality of assessment survey results indicate that the subject has arisk for atherosclerotic cardiovascular disease that is below a floorthreshold of risk or the subject has an incalculable risk foratherosclerotic cardiovascular disease; c) running all or a portion ofthe plurality of assessment survey results against a second plurality ofassessment filters of a second category class, wherein, when arespective filter in the second plurality of assessment filters isfired, the subject is provided with a warning corresponding to therespective filter, and wherein the second plurality of assessmentfilters comprises: an electrolyte blood level assessment filter that isfired at least when the plurality of assessment survey results indicatesthat the subject has had an abnormal electrolyte blood level, and akidney problem assessment filter that is fired at least when theplurality of assessment survey results indicates that the subject hashad a kidney problem, d) obtaining acknowledgment from the subject forthe warning issued to the subject by any filter in the second pluralityof filters; and e) proceeding with a fulfillment process when (i) nofilter in the first plurality of filters has been fired and (ii) thesubject has acknowledged each warning associated with each filter in thesecond plurality of filters that was fired, wherein the fulfillmentprocess comprises: storing an indication in a subject profile of aninitial order for the angiotensin II receptor blocker pharmaceuticalcomposition, communicating an over the counter drug facts label for theangiotensin II receptor blocker pharmaceutical composition to thesubject, and authorizing, upon confirmation from the subject that theover the counter drug facts label has been received and read, provisionof the angiotensin II receptor blocker pharmaceutical composition to thesubject.
 2. (canceled)
 3. The computer system of claim 1, wherein theangiotensin II receptor blocker pharmaceutical composition comprises anactive ingredient that is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylateor a pharmaceutically acceptable salt thereof.
 4. The computer system ofclaim 1, wherein the angiotensin II receptor blocker pharmaceuticalcomposition comprises an active ingredient that is azilsartan medoxomilor a pharmaceutically acceptable salt thereof.
 5. The computer system ofclaim 4, wherein, upon confirmation from the subject that the over thecounter drug facts label has been received and read, the subject isauthorized for provision of a dosage of from 40 mg to 80 mg per day ofthe active ingredient of the angiotensin II receptor blockerpharmaceutical composition.
 6. The computer system according to claim 1,wherein the active ingredient of the angiotensin II receptor blockerpharmaceutical composition comprises an active ingredient selected fromthe group consisting of candesartan, eprosartan, irbesartan, losartan,olmesartan, telmisartan, and valsartan. 7-22. (canceled)
 23. Thecomputer system of claim 1, wherein the first drug interactionassessment filter is fired when the plurality of assessment surveyresults indicates that the subject is taking a lithium medication. 24.The computer system of claim 1, wherein the first drug interactionassessment filter is fired when the plurality of assessment surveyresults indicates that the subject is taking a non-steroidalanti-inflammatory medication.
 25. The computer system of claim 1,wherein the first drug interaction assessment filter is fired when theplurality of assessment survey results indicates that the subject istaking a high blood pressure medication. 26-28. (canceled)
 29. Thecomputer system of claim 1, wherein the performed method furthercomprises, when the plurality of assessment survey results indicate thatthe subject has stage two hypertension: firing the blood pressureassessment filter; and transmitting, to the subject, advice to visit adoctor to discuss taking a prescription-strength blood pressuremedication.
 30. The computer system of claim 1, wherein the performedmethod further comprises, when the plurality of assessment surveyresults indicate that the subject is in hypertensive crisis: firing theblood pressure assessment filter; and transmitting, to the subject,advice to seek emergency medical attention.
 31. The computer system ofclaim 1, wherein the pooled cohort equation assessment filter is firedwhen the plurality of assessment survey results indicates that thesubject has a 10-year risk for atherosclerotic cardiovascular disease,as determined using the pooled cohort equation, that is less than 10%.32. The computer system of claim 31, wherein the pooled cohort equationassessment filter is fired when the plurality of assessment surveyresults indicates that the subject has an incalculable risk foratherosclerotic cardiovascular disease, as determined by one or moreinputs of the pooled cohort equation, including: A) the subject isyounger than forty years old, B) a total cholesterol level of thesubject is either less than 160 mg/dL or greater than 240 mg/dL, C) ahigh density lipoprotein cholesterol level of the subject is less than45 mg/dL or greater than 65 mg/dL, D) an untreated systolic bloodpressure of the subject is less than 100 mm Hg or greater than 140 mmHg, or E) a treated systolic blood pressure of the subject is less than120 mm Hg or greater than 160 mm Hg.
 33. The computer system of claim 1,wherein the method includes bypassing the firing of the pooled cohortequation assessment filter when the plurality of assessment surveyresults indicates that the subject has an incalculable risk foratherosclerotic cardiovascular disease but has an age that is above arisk threshold age.
 34. The computer system of claim 1, wherein theplurality of assessment survey results further comprises: a gender ofthe subject, a race of the subject, a blood pressure medication statusof the subject, a smoking status of the subject, a total cholesterollevel of the subject, a high density lipoprotein cholesterol level ofthe subject, whether the subject has ever had an atheroscleroticcardiovascular history including an atherosclerotic cardiovascular eventor a heart procedure, and a diabetes status of the subject; and thepooled cohort equation assessment filter incorporates the gender of thesubject, the age of the subject, the race of the subject, the bloodpressure medication status of the subject, the smoking status of thesubject, the total cholesterol of the subject, the high densitylipoprotein cholesterol level of the subject, the atheroscleroticcardiovascular history of the subject, and the diabetes status of thesubject to derive the risk for atherosclerotic cardiovascular disease.35. The computer system of claim 1, wherein the pooled cohort equationis implemented as a multivariable Cox proportional hazard regression.36. (canceled)
 37. The computer system of claim 1, wherein: the warningcorresponding to a respective filter in the second plurality ofassessment filters comprises a prompt for the subject to indicatewhether they have discussed the risk factor underlying the respectivefilter in the second plurality of assessment filters that was fired witha health care provider; and acknowledgement is obtained from the subjectwhen the subject indicates that they have discussed the risk factorunderlying the respective filter in the second plurality of assessmentfilters that was fired with a health care provider.
 38. The computersystem of claim 1, wherein the fulfillment process further comprises:storing a destination associated with the subject in the subjectprofile.
 39. The computer system of claim 1, wherein the fulfillmentprocess further comprises: coordinating shipping of the angiotensin IIreceptor blocker pharmaceutical composition to a physical addressassociated with the subject.
 40. (canceled)
 41. A computer system forrequalifying a human subject for over-the-counter delivery of anangiotensin II receptor blocker pharmaceutical composition for loweringblood pressure, the computer system comprising one or more processorsand a memory, the memory comprising non-transitory instructions which,when executed by the one or more processor, perform a re-fulfillmentmethod comprising, responsive to receiving a re-order request from thesubject for the angiotensin II receptor blocker pharmaceuticalcomposition: (a) conducting a reassessment survey of the subject therebyobtaining a plurality of reassessment survey results, wherein theplurality of reassessment survey results comprises: a systolic bloodpressure of the subject, a diastolic blood pressure of the subject,whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii)planning to become pregnant, whether the subject is taking a medicationthat interacts with the angiotensin II receptor blocker pharmaceuticalcomposition, whether the subject has experienced symptoms of hypotensionsince receiving their last provision of the angiotensin II receptorblocker pharmaceutical composition, whether the subject has developed anabnormal electrolyte blood level since receiving their last provision ofthe angiotensin II receptor blocker pharmaceutical composition, andwhether the subject has developed a kidney problem since receiving theirlast provision of the angiotensin II receptor blocker pharmaceuticalcomposition, (b) running all or a portion of the plurality ofreassessment survey results against a first plurality of reassessmentfilters of a first category class, wherein, when a respective filter inthe first plurality of reassessment filters is fired, the subject isdeemed not qualified for the angiotensin II receptor blockerpharmaceutical composition and the re-fulfillment process is terminatedwithout delivery of the angiotensin II receptor blocker pharmaceuticalcomposition to the subject, wherein the first plurality of reassessmentfilters comprise: a blood pressure reassessment filter that is fired atleast when the plurality of reassessment survey results indicates thesubject has hypertension, a pregnancy reassessment filter that is firedat least when the plurality of reassessment survey results indicates thesubject is pregnant or the subject is breastfeeding, a drug interactionreassessment filter that is fired at least when the plurality ofreassessment survey results indicates the subject is taking a medicationthat interacts with the angiotensin II receptor blocker pharmaceuticalcomposition a hypotension reassessment filter that is fired at leastwhen the plurality of reassessment survey results indicates that thesubject has experienced symptoms of hypotension since receiving theirlast provision of the angiotensin II receptor blocker pharmaceuticalcomposition, an electrolyte blood level reassessment filter that isfired at least when the plurality of reassessment survey resultsindicates that the subject has developed an abnormal electrolyte bloodlevel since receiving their last provision of the angiotensin IIreceptor blocker pharmaceutical composition, and a kidney problemreassessment filter that is fired at least when the plurality ofreassessment survey results indicates that the subject has developed akidney problem since receiving their last provision of the angiotensinII receptor blocker pharmaceutical composition; and (c) proceeding withthe re-fulfillment when (a) the re-fulfillment is not already terminatedby the firing of a filter in the first plurality of reassessmentfilters, wherein the re-fulfillment further comprises: storing anindication in the subject profile of a re-order for the angiotensin IIreceptor blocker pharmaceutical composition, communicating the over thecounter drug facts label for the angiotensin II receptor blockerpharmaceutical composition to the subject, and authorizing, uponconfirmation from the subject that the over the counter drug facts labelhas been received and read, a re-order provision of the angiotensin IIreceptor blocker pharmaceutical composition to the subject. 42-57.(canceled)
 58. A method for lowering blood pressure in a subject in needthereof, the method comprising: administering an angiotensin II receptorblocker pharmaceutical composition to a subject qualified forover-the-counter access to the angiotensin II receptor blockerpharmaceutical composition. 59-70. (canceled)